FFB BL CO-BR 2 HC-5 1N 38" STRYKER
Report
- Report Number
- 3004365956-2024-00054
- Event Type
- Malfunction
- Date Received
- July 12, 2024
- Date of Event
- March 9, 2024
- Report Date
- June 14, 2024
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GAT
- UDI-DI
- 14026704603395
- PMA / PMN Number
- K063778
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN# (B)(4). UDI#: (B)(4).
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
IT WAS REPORTED, "IN A TENORRHAPHY IN THE ACHILLES. AT THE TIME OF THE STITCH STEP, THE NEEDLE IS DISCONNECTED FROM THE FORCE FIBER SUTURE WITHOUT ANY FORCE HAVING BEEN EXERTED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
IT WAS REPORTED "IN A TENORRHAPHY IN THE ACHILLES. AT THE TIME OF THE STITCH STEP, THE NEEDLE IS DISCONNECTED FROM THE FORCE FIBER SUTURE WITHOUT ANY FORCE HAVING BEEN EXERTED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834670 | FFB BL CO-BR 2 HC-5 1N 38" STRYKER | SUTURE, NONABSORBABLE, SYNTHE | GAT | TELEFLEX MEDICAL | 74C2300160 | 14026704603395 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |