NA 05.001.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10886982128577), received between Mar 1, 2019 and Jan 7, 2026 — classified as 4 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (37 reports).

6 other recalls cover devices cleared under the same FDA submission (K043310); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Excessive Heating

  IT WAS REPORTED THAT THE ELECTRIC HANDPIECE DEVICE AND SAW ATTACHMENT DEVICE WERE HEATING UP DURING USE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995110 ↗
• MalfunctionDec 26, 2025Excessive Heating; Excessive Heating

  THIS IS REPORT 2 OF 3 OF THE SAME EVENT: IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ELECTRIC PEN DRIVE DEVICE BURNED A PATIENT DURING USE. IT WAS REPORTED THAT THE DEVICE WAS USED WITH RECIPROCATING SAW AND DRILL ATTACHMENT DEVICES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. PATIENT INVOLVEMENT AND INJURY WERE REPORTED. HOWEVER, IT IS UNCLEAR WHETHER ANY MEDICAL INTERVENTION WAS PROVIDED OR IF PROLONGED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Burn(s)

  MAUDE report 23896122 ↗
• MalfunctionDec 16, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE DRILL ATTACHMENT AND THE RECIPROCATING SAW ATTACHMENT WERE HEATING UP. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. THERE WAS NO DELAY REPORTED. IT WAS REPORTED THAT THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822315 ↗
• MalfunctionNov 3, 2025Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS NOT WORKING PROPERLY AND WAS HEATING UP. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. AL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23445098 ↗
• MalfunctionOct 9, 2025Excessive Heating; Excessive Heating

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A MANDIBULAR BILATERAL SAGITTAL SPLIT OSTEOTOMY PROCEDURE, THE SAW ATTACHMENT DEVICE AND PEN DRIVE DEVICE WERE BEING USED WHEN THE PATIENT HAD RECEIVED BURNS ON THEIR LIP DUE TO THE END ATTACHMENT OF THE PEN DRIVE DEVICE BECOMING EXTREMELY HOT WITH USE AND BURNING THE PATIENT. NO KNOWN INJURIES WERE REPORTED OTHER THAN EXTENDED RECOVERY AND INCREASED RISK OF INFECTION. NO REPORTS OF ANY MEDICAL INTERVENTION OR DELAYS IN THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED AT THIS TIME.

  Patient problems: Burn(s)

  MAUDE report 23253287 ↗
• MalfunctionNov 5, 2024Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED FROM CHILE THAT THE MOTOR DEVICE HEATED UP. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611074 ↗
• MalfunctionOct 3, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM AUSTRALIA THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE ELECTRIC PEN DRIVE DEVICE WOULD ONLY RUN IN REVERSE AND THE RECIPROCATING SAW ATTACHMENT DEVICE WAS HEATING UP. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360614 ↗
• MalfunctionJun 20, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING POST OP, IT WAS DISCOVERED THAT THE SAW ATTACHMENT DEVICE ACCESSORIES WERE DAMAGED AND DETACHED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575211 ↗
• MalfunctionJun 5, 2024Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED FROM SOUTH KOREA THAT AFTER A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE OVERHEATED SEVERELY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470937 ↗
• MalfunctionJun 4, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE SAW ATTACHMENT DEVICE OVERHEATED IN REPAIR. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458183 ↗
• MalfunctionMay 24, 2024Break; Leak/Splash; Break; Leak/Splash

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED FROM THE UNITED KINGDOM THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ELECTRIC PEN DRIVE DEVICE AND RECIPROCATING SAW ATTACHMENT DEVICE WERE DAMAGED AND OIL CAME OUT DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A THIRTY MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389809 ↗
• MalfunctionApr 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER REPROCESSING, IT WAS OBSERVED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE HAD A LEAK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201696 ↗
• MalfunctionFeb 20, 2024Break; Device Slipped; Detachment of Device or Device Component; Break; Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED FROM (B)(6) THAT THE TOP PIECE ON THE ATTACHMENT DEVICE HAD BROKEN OFF AND CAME LOOSE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741148 ↗
• MalfunctionJan 8, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM AUSTRALIA THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS OVERHEATING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462882 ↗
• MalfunctionDec 11, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM AUSTRALIA THAT THE RECIPROCATING SAW ATTACHMENT DEVICE HEATED UP. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304763 ↗
• MalfunctionOct 25, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED BY BRAZIL THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE HAD HEAT AND WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK GENERAL FUNCTION IN RUNNING MODE AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18006775 ↗
• MalfunctionSep 27, 2023Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED FROM SOUTH KOREA THAT THE RECIPROCATING SAW ATTACHMENT DEVICE BECAME TOO HOT AND TOO LOUD WHILE USING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823945 ↗
• MalfunctionJul 25, 2023Leak/Splash; Complete Loss of Power; Leak/Splash; Complete Loss of Power

  IT WAS REPORTED FROM SINGAPORE THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS JAMMED, HAD COMPONENT DAMAGE AND COULD NOT ENGAGE THE ATTACHMENT DEVICE. IT WAS ALSO NOTED THAT THE DEVICE TOOL COUPLING FAILED, WAS ROUGH TURNING AND THE HOUSING SEIZED UP. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR FUNCTION OF RELEASE SLEEVE, TOOL/SAW BLADE COUPLING, GENERAL FUNCTION IN RUNNING MODE AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING AND WAS LEAKING A BLACK SUBSTANCE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392774 ↗
• MalfunctionJun 27, 2023Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED FROM NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE MADE EXCESSIVE NOISE, HEATED UP, WAS VIBRATING AND THE MOVING PARTS DID NOT MOVE SMOOTHLY. THE DEVICE ALSO FAILED PRETESTS FOR GENERAL FUNCTION IN RUNNING MODE AND OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT FUNCTIONING PROPERLY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210126 ↗
• MalfunctionMay 24, 2023Excessive Heating; Excessive Heating

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM AUSTRALIA THAT THE ELECTRIC PEN DRIVE DEVICE AND RECIPROCATING SAW ATTACHMENT DEVICE WERE HEATING UP. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992167 ↗
• MalfunctionJan 20, 2023Excessive Heating; Excessive Heating

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM AUSTRALIA THAT THE ELECTRIC PEN DRIVE DEVICE AND RECIPROCATING SAW DEVICE WERE OVERHEATING DURING MINIMAL USE TOGETHER. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216861 ↗
• InjuryDec 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM INDIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE INNER SHAFT OF THE RECIPROCATING SAW ATTACHMENT DEVICE CAME OUT OR LOOSENED OUT FROM THE SAW. ACCORDING TO THE REPORTER, THE PROCEDURE WAS COMPLETED WITH DIFFICULTY AS A RESULT OF THE EVENT. IT WAS REPORTED THAT THERE WAS A THIRTY MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT SURGICAL INTERVENTION WAS REQUIRED, HOWEVER NO FURTHER DETAILS REGARDING THE TYPE OF INTERVENTION WAS REPORTED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 15986393 ↗
• InjuryOct 12, 2022Excessive Heating; Excessive Heating

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ELECTRIC PEN DRIVE DEVICE AND RECIPROCATING SAW ATTACHMENT DEVICE OVERHEATED AND BURNT THE PATIENT¿S LIP. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF SPARE DEVICES WERE AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THERE WAS PATIENT INJURY. THE REPORTER STATED THAT THE DEVICE WAS RETURNED BY THE BIOMEDICAL ENGINEERING DEPARTMENT; THEREFORE, NO INFORMATION WAS PROVIDED REGARDING THE EVENT DETAILS. IT WAS NOT REPORTED IF THERE WAS ANY MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION REQUIRED AS A RESULT OF THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Burn(s)

  MAUDE report 15586402 ↗
• MalfunctionJul 20, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM AUSTRALIA THAT THE SAW ATTACHMENT DEVICE WAS HEATING UP. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064338 ↗
• MalfunctionJul 6, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM AUSTRALIA THAT THE SAW ATTACHMENT DEVICE WAS HEATING UP DURING USE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14932399 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043310. One submission often covers many models, so check the product and lot details in each record.

• Z-0681-2017 · Nov 1, 2016 · Terminated
  Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
• Z-2783-2016 · Jun 24, 2016 · Terminated
  Light Adaptor for Small Battery Drive and Small Battery Drive II.
• Z-2784-2016 · Jun 24, 2016 · Terminated
  Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in
• Z-2199-2016 · May 31, 2016 · Terminated
  Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments ar
• Z-1313-2015 · Dec 19, 2014 · Terminated
  Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticati
• Z-0615-2014 · Apr 15, 2013 · Terminated
  Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and met