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NA 05.001.225Recalls & reported problems

Synthes GmbH · RECIPROCATING SAW ATTACHMENT FOR TRAUMA RECON SYSTEM · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Synthes reciprocating saw attachment for its trauma reconstruction system has 196 reports, 1 injury and no deaths. Most reports describe the attachment freezing and not moving, or the power cutting out, often found during service checks. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
197
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 10886982130051), received between Nov 22, 2017 and Sep 14, 2026 — classified as 1 injury, 196 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (162 reports).

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 18, 2026.

Reports received per month

Nov 2023: 4 reportsDec 2023: 0 reportsJan 2024: 4 reportsFeb 2024: 1 reportsMar 2024: 2 reportsApr 2024: 5 reportsMay 2024: 1 reportsJun 2024: 4 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 1 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 3 reportsMar 2025: 2 reportsApr 2025: 4 reportsMay 2025: 2 reportsJun 2025: 2 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 7 reportsFeb 2026: 4 reportsMar 2026: 6 reportsApr 2026: 1 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Jam162
  • Complete Loss of Power90
  • Appropriate Device Problem Term/Code Not Available26
  • Excessive Heating10
  • Premature Separation5
  • Overheating of Device4
  • Detachment of Device or Device Component3
  • Device Inoperable3

Patient problems

  • No Clinical Signs, Symptoms or Conditions178
  • No Consequences Or Impact To Patient13
  • No Known Impact Or Consequence To Patient5
  • Unspecified Tissue Injury1

Recent adverse event reports

The 25 most recent of 197 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 14, 2026Mechanical Jam; Complete Loss of Power

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50754730 ↗
  • MalfunctionAug 25, 2026Mechanical Jam; Complete Loss of Power

    It was reported that during service and evaluation, it was determined that the RECIPROCATING SAW ATTACHMENT FOR TRS device was frozen/would not move. It was noted in the service order that the device was not functioning. 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 2026. All available information has been disclosed.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50431840 ↗
  • MalfunctionAug 18, 2026Mechanical Jam

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50308125 ↗
  • MalfunctionMay 8, 2026Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT FOR TRS DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING ANYMORE PRIOR TO A SURGICAL PROCEDURE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25123740 ↗
  • MalfunctionMay 8, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT FOR TRS DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING ANYMORE PRIOR TO SURGERY. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25123203 ↗
  • MalfunctionApr 24, 2026Mechanical Jam

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. THIS EVENT DID NOT OCCUR DURING 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24983214 ↗
  • MalfunctionMar 25, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE DEVICE DID NOT WORK ANYMORE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24690767 ↗
  • MalfunctionMar 18, 2026Mechanical Jam

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. THIS EVENT DID NOT OCCUR DURING 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24629293 ↗
  • MalfunctionMar 10, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK ANYMORE. 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24560137 ↗
  • MalfunctionMar 10, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK ANYMORE. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24558723 ↗
  • MalfunctionMar 6, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK PRIOR TO SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24536772 ↗
  • MalfunctionMar 3, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24500961 ↗
  • MalfunctionFeb 23, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING ANYMORE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24417188 ↗
  • MalfunctionFeb 18, 2026Mechanical Jam; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WILL NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK GENERAL FUNCTION IN RUNNING MODE, AND CHECK OSCILLATION FREQUENCY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DEFECTIVE. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 2026. 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 24380084 ↗
  • MalfunctionFeb 9, 2026Mechanical Jam

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. THIS EVENT DID NOT OCCUR DURING 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 (B)(6) 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290491 ↗
  • MalfunctionFeb 2, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE DEVICE DID NOT WORK ANYMORE. 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24234289 ↗
  • MalfunctionJan 30, 2026Mechanical Jam

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24221476 ↗
  • MalfunctionJan 21, 2026Excessive Heating

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE RECIPROCATING SAW ATTACHMENT FOR TRS DEVICE OVERHEATED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24131933 ↗
  • MalfunctionJan 8, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT DURING PRE-SURGERY, THE DEVICE DID NOT WORK ANYMORE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 (B)(6) 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24006004 ↗
  • MalfunctionJan 6, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23974858 ↗
  • MalfunctionJan 6, 2026Mechanical Jam

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23974469 ↗
  • MalfunctionJan 5, 2026Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE WAS FROZEN/WILL NOT MOVE. IT WAS NOTED THAT THE DEVICE DID NOT WORK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK GENERAL FUNCTION IN RUNNING MODE AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. 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. 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 23964200 ↗
  • MalfunctionJan 2, 2026Mechanical Jam; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WILL NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR CURRENT VERSION, CHECK PINS LENGTH OF CONE SLEEVE, CHECK WITH TOP OF STERNUM, CHECK GENERAL FUNCTION IN RUNNING MODE, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DEFECTIVE. THIS EVENT DID NOT OCCUR DURING SURGERY. 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. 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 23943539 ↗
  • MalfunctionNov 10, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE 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. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK PROPERLY. THIS EVENT DID NOT OCCUR DURING 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23508787 ↗
  • MalfunctionOct 15, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE 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. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23303103 ↗

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Sources and updates

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