NA 03.043.023Recalls & reported problems
Synthes GmbH · COMPRESSION SCREW/ MEDIUM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982297228), received between Jan 17, 2023 and Jan 17, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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
Device problems
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, DURING A INTRA-OP CASE WHILE UTILIZING THE COMPRESSION DEVICE IN OUR ANS TNA PARAPATELLAR SET, THE COMPRESSION DEVICE WOULD NOT DISENGAGE FROM THE CONNECTING SCREW. THE SURGEON PROCEEDED TO REMOVE THE TWO DEVICES TOGETHER AS A UNIT AND SUBSEQUENTLY THREAD IN A NEW CONNECTING SCREW FROM THE TRAY. MAYBE A 10 SECOND DELAY OR ADDITION TO SURGICAL TIME. HOWEVER, WE STERILE PROCESSING REPORTED THAT THE COMPRESSION DEVICE AND CONNECTING SCREW WERE STILL COMPLETELY THREADED TOGETHER AND AS SUCH, LEFT OUT OF OUR INSTRUMENT SET. THEY TRIED SOAKING THE INSTRUMENTS TO LOOSEN THEM, CLAMPING THEM TO GET BETTER TORQUE FOR DISENGAGEMENT, ETC. TO NO AVAIL. THE LOT #'S IS NOT AVAILABLE AS THE COMPRESSION DEVICE IS STILL INSIDE AND THUS NOT VISIBLE, THE CONNECTING SCREW THAT HAD SOME SORT OF CLAMP ON IT DURING THE ATTEMPT TO DISENGAGE SUSTAINED DAMAGE WHICH SKEWS THE VISIBILITY OF THE LOT #. PATIENT CONSEQUENCES OR SURGERY RESULTS ARE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) COMPRESSION SCREW/ MEDIUM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16189375 ↗
Other INSTRUMENT, COMPRESSION devices
- ATTUNE 2545-01-042Depuy (Ireland) · INSTRUMENT, COMPRESSION153 reports
- ATTUNE 2545-11-041Depuy (Ireland) · INSTRUMENT, COMPRESSION78 reports
- ATTUNE 2545-05-550Depuy (Ireland) · INSTRUMENT, COMPRESSION54 reports
- ATTUNE 2545-05-551Depuy (Ireland) · INSTRUMENT, COMPRESSION34 reports
- NA 03.111.021Synthes GmbH · INSTRUMENT, COMPRESSION32 reports
- ATTUNE 2545-05-552Depuy (Ireland) · INSTRUMENT, COMPRESSION27 reports
- NA 03.211.400Synthes GmbH · INSTRUMENT, COMPRESSION25 reports
- VIPER PRIME 286750083Medos International Sàrl · INSTRUMENT, COMPRESSION18 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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