NA 311.43Recalls & reported problems
Synthes GmbH · HANDLE WITH QUICK COUPLING, SMALL · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes bone tap handle has 175 adverse event reports, with no deaths and 1 injury. The reports mostly describe handles breaking, including during sterilization, and quick-coupling parts sticking so attachments do not release. No recalls name this device, and reports rose to 14 in the latest 12 months from 7 in the prior 12 months.
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
- 176
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 10886982187390), received between Jan 5, 2017 and Sep 9, 2026 — classified as 1 injury, 175 malfunctions.
The most frequently reported specific device problem is “Break” (129 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.
Reports received per month
Most reported problems
Device problems
- Break129
- Device-Device Incompatibility29
- Contamination /Decontamination Problem11
- Crack5
- Device Contamination with Chemical or Other Material3
- Fracture2
- Material Twisted/Bent2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions92
- No Consequences Or Impact To Patient46
- No Patient Involvement39
- No Known Impact Or Consequence To Patient3
- Insufficient Information2
- Foreign Body In Patient1
- Injury1
Recent adverse event reports
The 25 most recent of 176 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691023 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50504742 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50504497 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50496374 ↗MalfunctionJun 9, 2026Break
IT WAS REPORTED THAT THE HANDLE WAS BROKEN DURING STERILIZATION PROCESS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443514 ↗MalfunctionMay 19, 2026Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT ON AN UNKNOWN DATE, QUICK COUPLING SMALL DRIVER HANDLE WAS STICKING/NOT RELEASING WHEN DRIVER ATTACHMENTS ARE INSERTED/REMOVED. IT WAS NOTICED DURING A PROCEDURE WHEN TRYING TO REMOVE AN ATTACHMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216439 ↗MalfunctionMay 14, 2026No Apparent Adverse Event
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT SURGERY FOR VACHP REMOVAL ON THE CLAVICLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. BEFORE SURGERY, WHEN THE DISTRIBUTOR DELIVERED THE PRODUCT IN QUESTION TO THE HOSPITAL, IT WAS FOUND THAT THE HANDLE WAS CHIPPED. THE PRODUCT WAS NOT USED IN THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174054 ↗MalfunctionApr 8, 2026Device-Device Incompatibility
IT WAS REPORTED THAT WHEN THEY WENT TO MEASURE WITH THE DEPTH GAUGE AND THE PROBE FELL OFF. QUICK CONNECT WAS ALSO UNABLE TO OPEN AND LATCH ONTO SCREWDRIVER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815997 ↗MalfunctionApr 8, 2026Device-Device Incompatibility
IT WAS REPORTED THAT WHEN THEY WENT TO MEASURE WITH THE DEPTH GAUGE AND THE PROBE FELL OFF. QUICK CONNECT WAS ALSO UNABLE TO OPEN AND LATCH ONTO SCREWDRIVER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815940 ↗MalfunctionMar 18, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626394 ↗MalfunctionJan 30, 2026Contamination /Decontamination Problem
IT WAS REPORTED MULTIPLE COMPOSITE HANDLE TRAUMA PRODUCTS ARE LEAKING CAUSING STERILITY ISSUES. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223563 ↗MalfunctionJan 26, 2026Break
IT WAS REPORTED MULTIPLE DEVICES ARE NO LONGER FUNCTIONAL. THESE ISSUES DID NOT IMPACT PATIENT OUTCOMES. BELOW DEVICES WERE FOUND TO BE "RELEASE MECHANISM BROKEN" DURING INSPECTION: 03.043.028. BELOW DEVICES WERE FOUND TO BE "STRIPPED THREADS" DURING INSPECTION: 03.120.022, 312.648, 323.029. BELOW DEVICES WERE FOUND TO BE "NUT STUCK ON SLEEVE" DURING INSPECTION: 03.037.017, 03.037.016. BELOW DEVICES WERE FOUND TO BE "HANDLE LEACHING/SPD WIL NOT STERILIZE" DURING INSPECTION: 03.100.018. BELOW DEVICES WERE FOUND TO BE "BROKEN HANDLE" DURING INSPECTION: 311.43. BELOW DEVICES WERE FOUND TO BE "STRIPPED DRILL CONNECTION AND 2ND IS COLD WELDED TO A SCHANZ PIN" DURING INSPECTION: 393.103. BELOW DEVICES WERE FOUND TO BE "BROKEN SLIDING MECHANISM" DURING INSPECTION: 319.091. BELOW DEVICES WERE FOUND TO BE "NOT SNAPPING IN" DURING INSPECTION: 03.120.018. 03.120.017 BELOW DEVICES WERE FOUND TO BE "STRIPPED" DURING INSPECTION: 03.010.151, 314.467, 03.900.042, 03.130.010, 314.453, 03.010.150, 03.010.152. BELOW DEVICES WERE FOUND TO BE "NOT WORKING PROPERLY" DURING INSPECTION: 329.15. BELOW DEVICES WERE FOUND TO BE "NOT LOCKING TENSION BETWEEN TRIGGER PULLS" DURING INSPECTION: 03.221.015. BELOW
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24179193 ↗MalfunctionJan 20, 2026Contamination /Decontamination Problem
IT WAS REPORTED THE SCREWDRIVER HANDLES ARE LEAVING STAINS ON PEEL PACKS DURING STERILIZATION, THE TIP OF DEPTH GAUGE BROKE DURING CLEANING AND SCREWDRIVER SHAFT IS WORN OUT. EVENT WAS NOTED DURING STERILE PROCESSING AND FIELD INSPECTION. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24120917 ↗MalfunctionJan 20, 2026Contamination /Decontamination Problem
MULTIPLE COMPOSITE HANDLES HAVE BEEN FLAGGED BY THE ACCOUNT DUE TO LEAKING/BROWN STAINING IN THE TRAYS; CAUSING STERILITY CONCERN. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24116501 ↗MalfunctionNov 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, THE SURGEON WAS DOING A ORIF OF A DISTAL RADIUS WHEN THE SLIVER SLIDING PART OF THE QC HANDLE WOULD NOT ENGAGE WITH THE DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582670 ↗MalfunctionAug 12, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST OPERATIVE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22783999 ↗MalfunctionJun 9, 2025Break; Break
IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, THE METAL PART WAS DISENGAGED FROM THE MAIN PART OF THE HANDLE, BROKEN IN TWO PIECES. SURGERY WAS DELAYED BY TWO MINUTES DUE TO THE EVENT. A REPLACEMENT HANDLE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22166467 ↗MalfunctionMay 26, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025 THE SCREW HANDLE WAS FOUND SPLIT DURING TRAY SET UP IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084306 ↗MalfunctionMay 21, 2025Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER HANDLE BROKE DURING PROCEDURE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062463 ↗MalfunctionApr 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, DURING THE CASE, THE QUICK CONNECT HANDLE AND T15 SCREWDRIVER SHAFT BECAME STUCK TOGETHER. THE QUICK CONNECT HANDLE IS NOW STUCK IN RELEASE MODE, BUT THE T15 CANNOT BE REMOVED. THERE WAS NO SURGICAL DELAY. SURGEON OPENED OTHER SETS FOR SCREWDRIVERS. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21903839 ↗MalfunctionJan 15, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT SCREW REMOVAL ON (B)(6) 2025. DURING THE PROCEDURE, A HANDLE BROKE DURING USE. SURGERY WAS COMPLETED SUCCESSFULLY WITH ONE MINUTE OF SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. PATIENT OUTCOME WAS UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21161645 ↗MalfunctionNov 21, 2024Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT A TRAUMA PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE QC SCREWDRIVER HANDLE CAME APART INTO SEVERAL PIECES. ALL FRAGMENTS WERE REMOVED. ANOTHER SET WAS OPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20750876 ↗MalfunctionOct 10, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON WAS USING COMPLAINED ITEM AND NOTED THAT THE QUICK COUPLING FEATURE OF THE INSTRUMENT HAD FAILED. THE SPRING MECHANISM INSIDE THE INSTRUMENT SEEMED TO HAVE STOPPED WORKING AND THE INSTRUMENT NO LONGER SUCCESSFULLY HELD AND LOCKED THE VARIOUS AO QUICK COUPLING SCREWDRIVER SHAFTS AND OTHER INSTRUMENTS WITH THE MATCHING COUPLING IN PLACE. THIS ITEM WAS DEEMED TO BE NO LONGER FUNCTIONAL AND WAS SUBSEQUENTLY DISCARDED. A REPLACEMENT IS REQUIRED. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20418939 ↗MalfunctionSep 19, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 , THE SCREWDRIVER HANDLE BROKE DURING CASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20257936 ↗MalfunctionSep 11, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE BOTTOM OF HANDLE CRACKED AND BROKE APART. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189694 ↗
Other TAP, BONE devices
- NA 311.01Synthes GmbH · TAP, BONE106 reports
- NA 311.431Synthes GmbH · TAP, BONE70 reports
- NA 03.424.124Synthes GmbH · TAP, BONE1 recall7 reports
- NA 03.424.126Synthes GmbH · TAP, BONE1 recall0 reports
- A.L.P.S.® 8241-50-170Biomet Orthopedics, LLC · TAP, BONE1 recall0 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · TAP, BONE1 recall0 reports
- NA 311.44Synthes GmbH · TAP, BONE41 reports
- Invictus 17109-055Alphatec Spine, Inc. · TAP, BONE22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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