USSRecalls & reported problems across all models
Synthes GmbH · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 67
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 15 models of USS by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and Jun 9, 2026 — classified as 7 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Calibration Problem” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported USS problems
Device problems
- Calibration Problem29
- Break15
- Material Integrity Problem12
- Mechanical Problem4
- Material Twisted/Bent2
- Unintended Movement2
- Compatibility Problem1
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient9
- No Patient Involvement8
- Failure of Implant4
- No Known Impact Or Consequence To Patient3
- Insufficient Information2
- No Code Available1
USS models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- USS 03.602.042WRENCH29 reports
- USS 03.607.005ORTHOPEDIC MANUAL SURGICAL INSTRUMENT16 reports
- USS 03.603.108ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- USS 04.607.402APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- USS 03.607.006ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- USS 03.607.009PLIERS, SURGICAL2 reports
- USS 04.602.890Orthosis, spondylolisthesis spinal fixation2 reports
- USS 04.602.950ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- USS 04.607.280Orthosis, spondylolisthesis spinal fixation2 reports
- USS 03.607.003ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- USS 03.621.011ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- USS 04.607.412APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- USS 388.274TAP, BONE1 report
- USS 388.357TRAY, SURGICAL, INSTRUMENT1 report
- USS 498.813Orthosis, spondylolisthesis spinal fixation1 report
Recent USS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Material Integrity Problem
IT WAS REPORTED THAT 9.0MM TI DC USS SCR 50MM TH L F/6.0MM RD BROKE INTRAOPERATIVELY DURING A T10-PELVIS REVISION PROCEDURE. WHILE CHANGING THE LEFT ILIAC SCREW, THE SWIZZLE STICK BROKE ON THE SCREW HEAD, STRIPPING THE FIRST COUPLE OF THREADS OF THE SCREW. THE AFFECTED SIDE REQUIRED REPLACEMENT TWO TIMES AS THE ISSUE RECURRED. THE PRODUCT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. THERE WAS NO REPORTED PATIENT OR USER HARM, BUT THE SURGERY WAS PROLONGED BY 40 MINUTES AS THE PATIENT REMAINED UNDER ANESTHESIA LONGER DURING ATTEMPTS TO REMOVE THE BROKEN SCREW. THE EVENT RESULTED IN A CORRECTIVE INVASIVE PROCEDURE WHERE THE DEVICE WAS REPLACED/REVISED.
Patient problems: Insufficient Information
MAUDE report 25448833 ↗InjuryJun 9, 2026Material Integrity Problem
IT WAS REPORTED THAT 9.0MM TI DC USS SCR 50MM TH L F/6.0MM RD BROKE INTRAOPERATIVELY DURING A T10-PELVIS REVISION PROCEDURE. WHILE CHANGING THE LEFT ILIAC SCREW, THE SWIZZLE STICK BROKE ON THE SCREW HEAD, STRIPPING THE FIRST COUPLE OF THREADS OF THE SCREW. THE AFFECTED SIDE REQUIRED REPLACEMENT TWO TIMES AS THE ISSUE RECURRED. THE PRODUCT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. THERE WAS NO REPORTED PATIENT OR USER HARM, BUT THE SURGERY WAS PROLONGED BY 40 MINUTES AS THE PATIENT REMAINED UNDER ANESTHESIA LONGER DURING ATTEMPTS TO REMOVE THE BROKEN SCREW. THE EVENT RESULTED IN A CORRECTIVE INVASIVE PROCEDURE WHERE THE DEVICE WAS REPLACED/REVISED.
Patient problems: Insufficient Information
MAUDE report 25448825 ↗MalfunctionAug 12, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT IN THEATRE, WHEN USING THE KIT, ONE OF THE POSTS BROKE OFF IN THE SCREW HEAD INTRAOPERATIVELY. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. THIS DID NOT CAUSE ANY DELAY, AS THE SURGEON IS VERY EXPERIENCED WITH THIS KIT. THERE WERE ALTERNATIVE OPTIONS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786674 ↗MalfunctionOct 3, 2024Calibration Problem; Calibration Problem
THE FOLLOWING ITEM FAILED FOR TORQUE TESTING ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT INVOLVES ONE 12NM TORQ LIMITING WRENCH F/ DUAL-OP USS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20360573 ↗MalfunctionSep 6, 2024Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AUGUST 9, 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157641 ↗MalfunctionSep 6, 2024Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON (B)(6) 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157144 ↗MalfunctionAug 26, 2024Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON JULY 30, 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL , IT WAS OBSERVED THAT THE T-HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20071454 ↗MalfunctionDec 28, 2023Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE DISTRIBUTION CENTER, IT WAS OBSERVED THAT THE TORQUE LIMITING WRENCH WAS OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED LOW. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18415923 ↗MalfunctionNov 24, 2023Calibration Problem; Calibration Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT FOLLOWING ITEM DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING. ITEM REMOVED FROM SET BELOW AND WILL BE DELIVERED TO MAILROOM FOR DELIVERY TO PQS ROOM. THIS REPORT IS FOR ONE (1) 12NM TORQ LIMITING WRENCH F/ DUAL-OP USS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18205091 ↗InjuryMar 10, 2023Mechanical Problem; Mechanical Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY TO IMPLANT THE EXPEDIUM SACROILIAC USS. THEN, THE SURGEON RE-PERFORMED THE PROCEDURE DUE TO LOOSENING OF THE ILIAC SCREWS. THE SURGEON REMOVED THE 100MM SCREWS AND PLACED 70MM SCREWS, KEEPING THE SAME SYSTEM OF ILIAC CONNECTORS THAT THE PATIENT HAD PLACED IN THE INITIAL SURGERY. THIS REPORT INVOLVES ONE 8.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 16523510 ↗InjuryMar 10, 2023Mechanical Problem; Mechanical Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY TO IMPLANT THE EXPEDIUM SACROILIAC USS. THEN, THE SURGEON RE-PERFORMED THE PROCEDURE DUE TO LOOSENING OF THE ILIAC SCREWS. THE SURGEON REMOVED THE 100MM SCREWS AND PLACED 70MM SCREWS, KEEPING THE SAME SYSTEM OF ILIAC CONNECTORS THAT THE PATIENT HAD PLACED IN THE INITIAL SURGERY. THIS REPORT INVOLVES ONE 8.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 16523504 ↗MalfunctionNov 28, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE 12NM TORQ LIMITING WRENCH F/ DUAL-OP USS HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 12NM TORQ LIMITING WRENCH F/ DUAL-OP USS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15870111 ↗MalfunctionNov 23, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED THAT DURING EVALUATION ON AN UNKNOWN DATE, THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. THE ISSUE WAS FOUND DURING TESTING AT SERVICE AND REPAIR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15851255 ↗MalfunctionOct 25, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING EVALUATION, THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. THE ISSUE WAS FOUND DURING TESTING AT SERVICE AND REPAIR. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15665428 ↗MalfunctionOct 21, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING EVALUATION, THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. THIS WAS DISCOVERED DURING TESTING AT SERVICE AND REPAIR. THIS REPORT INVOLVES ONE 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15651976 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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