FIBULINK® SYNDESMOSIS REPAIR KIT/SS
Report
- Report Number
- 3013401747-2021-00067
- Event Type
- Malfunction
- Date Received
- November 18, 2021
- Date of Event
- October 24, 2021
- Report Date
- October 25, 2021
- Manufacturer
- AKROS MEDICAL, INC
- Product Code
- HTN
- UDI-DI
- 00863176000300
- PMA / PMN Number
- K173550
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H6: PART # FGS-1000. SYNTHES LOT # 21E018. SUPPLIER LOT # 21E018. RELEASE TO WAREHOUSE DATE: AUGUST 11, 2021. EXPIRATION DATE: JULY 1, 2024. SUPPLIER: ROBLING MEDICAL, INC. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. A PHOTO INVESTIGATION WAS PERFORMED BASED ON THE IMAGES. THE IMAGES WERE REVIEWED AND THE COMPLAINT CONDITION IS NOT CONFIRMED. THERE ARE NO VISUAL DEFECTS OR DAMAGE VISIBLE ON THE FIBULINK KIT IN THE PROVIDED IMAGES. THE DRILL BIT IS A PART OF THE FGS-1000 KIT AND HAS BEEN CONFIRMED BROKEN. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGE) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
(B)(4). DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR: THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE PROCEDURE, THE DRILL BIT WAS BROKEN IN PATIENT AT STEP THE 1/3 TUBULAR. THERE WAS AN UNKNOWN SURGICAL DELAY. IT WAS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED OR IF THERE WERE PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) FIBULINK® SYNDESMOSIS REPAIR KIT/SS THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1737020 | FIBULINK® SYNDESMOSIS REPAIR KIT/SS | WASHER, BOLT NUT | HTN | AKROS MEDICAL, INC | FGS-1000 | 21E018 | 00863176000300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Male |