FDA Adverse Event
Injury
Summary report: N
FW BPB #2 SUTR,BLU W/NDL
MDR report key: 15137910
·
Received August 1, 2022
Report
- Report Number
- 1220246-2022-05331
- Event Type
- Injury
- Date Received
- August 1, 2022
- Date of Event
- June 29, 2022
- Report Date
- August 1, 2022
- Manufacturer
- ARTHREX, INC.
- Product Code
- GAT
- UDI-DI
- 00888867279131
- PMA / PMN Number
- K122374
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT WHO WAS TREATED WITH THE FIBERWIRE DEVICE TWO WEEKS BEFORE THE (B)(6) 2022 NEEDED A REVISION SURGERY FOR OTHER REASONS. DURING THE REVISION SURGERY ON THE (B)(6) 2022 THE SURGEON NOTICED THAT THE FIBERWIRE SUTURE HAD TORN. NO FURTHER INFORMATION RECEIVED. UPDATE (B)(6) 2022: IT WAS CONFIRMED THAT THE TORN SUTURES OF THE DEVICE WERE NOT THE REASON FOR THE REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2333246 | FW BPB #2 SUTR,BLU W/NDL | SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | ARTHREX, INC. | FW BPB #2 SUTR,BLU W/NDL | UNK | 00888867279131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |