FDA Adverse Event
Injury
Summary report: N
SNAPFIX SCREW FULL THREADED Ø2.0MM - LENGTH 12MM
MDR report key: 16378842
·
Received February 15, 2023
Report
- Report Number
- 3012966183-2023-00003
- Event Type
- Injury
- Date Received
- February 15, 2023
- Date of Event
- January 13, 2023
- Report Date
- February 15, 2023
- Manufacturer
- TYBER MEDICAL
- Product Code
- HWC
- PMA / PMN Number
- K153575
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
DEVICE NOT RETURNED; THEREFORE, A DEVICE EVALUATION WAS NOT CONDUCTED. PHOTOGRAPHIC EVIDENCE WAS PROVIDED WHICH SHOWED THE DEVICE WAS FRACTURED. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED . LOT 226421 WAS MFG. 8-5-2021. LOT 226421 HAD 250 PIECES. THE LOT DID NOT HAVE ANY NON-CONFORMANCES OR CAPAS. LOT MET ALL SPECIFICATIONS. HISTORICAL DATA REVIEW IDENTIFIED 1 OTHER COMPLAINT RELATED TO LOT 226421 FOR A SIMILAR ISSUE. THERE IS NO IMAGING, X-RAYS, FLUOROSCOPY, MRI ETC. OR ADDITIONAL INFORMATION PROVIDED BY THE COMPLAINANT THAT CAN CONFIRM THE COMPLAINT EVENT. THE ROOT CAUSE IS INDETERMINATE.
Description of Event or Problem · 0
COULDN'T SNAP OFF THE STEM ON THE SNAP OFF WHICH RESULTED IN FRACTURING THE OSTEOTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1317562 | SNAPFIX SCREW FULL THREADED Ø2.0MM - LENGTH 12MM | SCREW | HWC | TYBER MEDICAL | FSS212 | 226421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |