NA 351.16JRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10886982193742), received between Jan 9, 2017 and May 7, 2026 — classified as 1 injury, 49 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Break

  IT WAS REPORTED ON (B)(6) 2026 GASKET CAME DETACHED FROM HANDLE DURING REAMING. SURGEON WAS ABLE TO COMPLETE THE CASE BY APPLYING PRESSURE TO THE POWER DRILL WHILE REAMING AND HOLDING REAMING SHAFT DURING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111219 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT THERE WAS A BROKEN ADAPTER. EVENT OCCURRED PREOPERATIVELY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067714 ↗
• MalfunctionMar 10, 2026Device Slipped

  IT WAS REPORTED THAT DURING INSPECTION IT WAS IDENTIFIED THAT THE DEVICE NOT LOCKING ON. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559479 ↗
• MalfunctionMar 4, 2026Device-Device Incompatibility

  IT WAS REPORTED ON FEB 19, 2026, THAT UPON INSPECTION OF A NEW FLEXIBLE REAMER PAN, 3 REAMERS WERE FOUND TO BE DULL, AND THE COUPLING MECHANISM WAS MALFUNCTIONING (POPS OFF REAMER SHAFT). THIS WAS BEFORE ANY CASES WERE PERFORMED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505435 ↗
• MalfunctionFeb 17, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT INSERT-HANDLE, AIM-ARM 125° F/STAT DIST LOCK, BLADE/SCREW GUIDE SLEEVE, DRILLSL YELL, TROCAR YELL, BUTTRESS/COMPR-NUT, SCREW INSERTER, CONNECSCR F/TFNA HELICAL BLADE+SCR, DHS® TRIPLE REAMER, COMPLETE, WITH LONG REAMER, AND FLEX SFT CONNECTOR FOR USE JACOBS CHUCK WERE ASSOCIATED WITH ISSUES INCLUDING IMPROPER POSITIONING OF GUIDE WIRES BY INSERTION HANDLES AND GUIDES, DEFORMATION OF T HANDLES FOR LAG SCREWS MAKING INSERTION DIFFICULT, DAMAGE TO THE DHS REAMER RENDERING IT UNSAFE FOR USE, REAMER ADAPTERS BECOMING JAMMED, AND A BENT RADIOGRAPHIC RULER. THE EVENT OCCURRED PRE-OPERATIVELY AND DID NOT INVOLVE THE PATIENT, NOR DID IT OCCUR DURING STERILE PROCESSING OR FIELD INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363860 ↗
• MalfunctionFeb 9, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. T HANDLES FOR LAG SCREWS ARE DEFORMED AND DIFFICULT TO INSERT THE LAG SCREW ON FOR INSERTION. DHS REAMER IS DAMAGED AND NOT SAFE FOR USE. REAMER ADAPTERS ARE STARTING TO BECOME JAMMED ONTO REAMER. RADIOGRAPHIC RULER BENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299818 ↗
• MalfunctionFeb 9, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. T HANDLES FOR LAG SCREWS ARE DEFORMED AND DIFFICULT TO INSERT THE LAG SCREW ON FOR INSERTION. DHS REAMER IS DAMAGED AND NOT SAFE FOR USE. REAMER ADAPTERS ARE STARTING TO BECOME JAMMED ONTO REAMER. RADIOGRAPHIC RULER BENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299809 ↗
• MalfunctionFeb 9, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. T HANDLES FOR LAG SCREWS ARE DEFORMED AND DIFFICULT TO INSERT THE LAG SCREW ON FOR INSERTION. DHS REAMER IS DAMAGED AND NOT SAFE FOR USE. REAMER ADAPTERS ARE STARTING TO BECOME JAMMED ONTO REAMER. RADIOGRAPHIC RULER BENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299785 ↗
• MalfunctionJan 22, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE EVEN THOUGH THE CONNECTION IS SUPPOSED TO CONNECT, THE CONNECTION WAS BASICALLY LOOSE. THE SALES REP WAS ABLE TO JUST DISCONNECT WITH A PUSH OF HIS THUMB, RATHER THAN USE THE MECHANISM TO DISENGAGE. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21211030 ↗
• MalfunctionDec 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE EXTRACTOR SHAFT FOR XL25 DOES NOT MATE AS APPROPRIATE WITH FLEXIBLE SHAFT CONNECTOR FOR JACOBS CHUCK. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20952340 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT WAS BROKE INTRAOPERATIVELY AND FULLY DISASSEMBLED DURING SURGERY, RENDERING THAT PIECE NO LONGER FUNCTIONAL. THERE WAS A 45 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE FLEX SFT CONNECTOR FOR USE JACOBS CHUCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643454 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FLEXIBLE SHAFT WAS NOT CONNECTING. ANOTHER REAMER SET WAS OPENED AND USED. LOT NUMBER WAS ILLEGIBLE. THERE WAS MINIMAL DELAY OF CASE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE FLEX SFT CONNECTOR FOR USE JACOBS CHUCK FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18646496 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE COUPLING DEVICE BROKE DURING CLEANING IN THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519044 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT ON DECEMBER 6, 2023, IN FLEXIBLE REAMER COUPLING SCREW, ONE OF THE LITTLE PINS APPEARED TO BE MISSING. IT WAS THERE IN THE WHOLE COUPLING TOGETHER AND WHEN IT CAME OUT OF WASH, NO PIN WAS THERE. THE DEVICE IS NOT USABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR FLEX SFT CONNECTOR FOR USE JACOBS CHUCK FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418412 ↗
• MalfunctionNov 21, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON OCTOBER 31,2023 THE FLEXIBLE SHAFT CONNECTOR FOR JACOBS CHUCK, QUICK COUPLING, CANNULATED CAME APART AND IT WAS FOUND THAT THE SCREW THAT HOLDS IT ALL TOGETHER WAS STRIPPED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) FLEX SFT CONNECTOR FOR USE JACOBS CHUCK THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185543 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON OCTOBER 27, 2023, THE FLEXIBLE REAMER SET FOR IM NAILS WAS MISSING A COMPONENT NEEDED FOR A SURGICAL CASE. THERE WAS NO MISSING INSTRUMENT REPORT ATTACHED TO THE SET. THE MISSING COMPONENT WAS REPLACED BY A BORROWED PART FROM ANOTHER HOSPITAL. THE EVENT HAD A SIGNIFICANT IMPACT ON THE SURGICAL CASE. THE SURGICAL TEAM WAITED ONE HOUR FOR ANOTHER ADAPTER TO BE SENT OVER FROM THE HOSPITAL AND WAITED ANOTHER 15 MINUTES FOR STERILIZATION. THIS ADDED CLOSE TO 1.5 HOURS OF CASE DELAY WHERE THE PATIENT WAS LYING OPEN ON THE TABLE, WITH THE ACETABULAR PORTION OF THE CASE DONE BUT WAITING FOR FEMORAL PREPARATION. THIS MEANT 1.5 HOURS OF ADDITIONAL ANESTHESIA TIME, OR TIME, BLOOD LOSS, AND INCREASED INFECTION RISK. DUE TO BLEEDING FROM THE FEMORAL CANAL, WHICH COULD NOT BE STOPPED WITH TOPICAL TXA OR BONE WAX, THE PATIENT¿S BLOOD LOSS WENT FROM 300CC TO 1 LITER. THE PATIENT TOLERATED THE BLOOD LOSS WELL AND WAS STABLE AT DISCHARGE. THIS REPORT INVOLVES ONE FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18181787 ↗
• MalfunctionAug 9, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE PEELING THE PACKING OF THE INSTRUMENTS IN CENTRAL STERILE PROCESSING IT WAS FOUND THAT THE FLEXIBLE SHAFT CONNECTOR WAS BROKEN IN 2 PIECES. IT IS MISSING THE THREADED SCREW THAT HOLDS THE QC COLLAR ON THE BODY. THE ITEM WAS NOT USED IN SURGERY AND DID NOT INVOLVE A PATIENT. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) FLEXIBLE SHAFT CONNECTOR FOR USE WITH (B)(6). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491034 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE 13MM SLEEVE DID NOT FULLY ENGAGE INTO THE BLUE HANDLE. A LARGE AO CONNECT KEPT DISENGAGING THE REAMER SHAFT, UPON OPENING ANOTHER ONE, IT COULD NOT DISENGAGED FROM THE REAMER SHAFT UNTIL HIT WITH MALLET. THERE WAS A 3 MINUTES SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) FLEX SFT CONNECTOR FOR USE JACOBS CHUCK. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456596 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  HOLD NB II 03/1IT WAS REPORTED THAT ON (B)(6) 2023, THE 13MM SLEEVE DID NOT FULLY ENGAGE INTO THE BLUE HANDLE. A LARGE AO CONNECT KEPT DISENGAGING THE REAMER SHAFT, UPON OPENING ANOTHER ONE, IT COULD NOT DISENGAGED FROM THE REAMER SHAFT UNTIL HIT WITH MALLET. THERE WAS A 3 MINUTES SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES THREE(3) DEVICES. THIS REPORT IS FOR ONE (1) FLEX SFT CONNECTOR FOR USEJACOBS CHUCKTHIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455969 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE REAMING, THE INSTRUMENT DISCONNECTED FROM THE REAMER SHAFT MULTIPLE TIMES. IT IS BELIEVED THAT THE CONNECTION IS WORN OUT FROM REPEATED USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED AND NO PATIENT CONSEQUENCES. AND THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR ONE (1) FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455899 ↗
• MalfunctionJan 20, 2023Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE UPON ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY, THE CONSULTANT NOTICED THAT THE ADAPTOR WAS IN PIECES AND WAS NOT ABLE TO BE REASSEMBLED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) FLEX SFT CONNECTOR FOR USE JACOBS CHUCK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218719 ↗
• MalfunctionNov 14, 2022Crack; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, INSTRUMENTS WERE UNABLE TO STERILIZE OR ASSEMBLE. THERE WERE CHIPPING AND CRACKING AND UNABLE TO USE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) FLEX SFT CONNECTOR FOR USE JACOBS CHUCK. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15787615 ↗
• MalfunctionJun 29, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN USA AS FOLLOWS: IT WAS REPORTED THAT ON JUN 1, 2022, DURING TNA TIBIAL NAIL CASE, THE FLEX SFT CONNECTOR FOR USE JACOBS CHUCK WOULD NOT FIT INTO A STRYKER POWER JACOB'S CHUCK. THEN IT WAS FOUND THAT THE BASE OF THE ITEM WAS TRIANGULAR IN SHAPE WHICH IS DIFFERENT THAN ALL THE OTHER ONES. SAME PART NUMBER, JUST LOOKS LIKE THE ITEM IS DEFECTED. THE DIFFERENCE BETWEEN A NORMAL ONE AND THE DEFECTIVE ONE CAN BE SEEN. THE DEFECTIVE ONE HAS A TRIANGULAR SHAPE BASE. EACH SCREW WAS PUT IN BY HAND TO FINISH THE CASE. THERE WAS A SURGICAL DELAY OF 5 MINUTES. SURGERY COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCE IS UNKNOWN. CONCOMITANT DEVICE REPORTED: TIBIAL NAIL-ADVANCED / 10 315 / STERILE (PART: 04.043.225S; LOT: 589P569; QUANTITY: 1). UNK - SCREWS: NAIL DISTAL LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE FLEX SFT CONNECTOR FOR USE JACOBS CHUCK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853114 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A FLEXIBLE SHAFT CONNECTOR FOR USE WITH A JACOBS CHUCK WAS FOUND WITH A NOTE STATING THAT IT WAS BROKEN. PATIENT INVOLVEMENT IS UNKNOWN. THIS REPORT IS FOR A FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657263 ↗
• MalfunctionFeb 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FLEXIBLE SHAFT CONNECTOR WAS NOT HOLDING THE REAMER SHAFT. THE ISSUE WAS DISCOVERED UPON ROUTINE INSPECTION WHILE RESTOCKING THE TRAY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE FLEX SFT CONNECTOR FOR USE JACOBS CHUCK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543283 ↗