SPEEDTRAP WHITE 30MM 4PK
Report
- Report Number
- 1221934-2018-54983
- Event Type
- Malfunction
- Date Received
- October 17, 2018
- Date of Event
- January 26, 2018
- Report Date
- January 27, 2018
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL
- Product Code
- GAT
- UDI-DI
- 10886705027163
- PMA / PMN Number
- K161638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PRODUCT COMPLAINT # (B)(4). 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. 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. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART 223749, LOT L193694 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. THEREFORE, WE CANNOT DETERMINE WHAT CAUSED THE USER TO EXPERIENCE THE REPORTED EVENT, WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED, AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4).
IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THE MANUFACTURER CONTACT NAME HAS BEEN UPDATED AS (B)(4). CONTACT PHONE NUMBER AND EMAIL ADDRESS HAVE BEEN UPDATED ACCORDINGLY.
AWARENESS DATE REPORTED ON FOLLOW UP 3 REPORT AS JANUARY 27, 2018 BUT SHOULD HAVE BEEN DECEMBER 17, 2018. AWARENESS DATE REPORTED ON FOLLOW UP 5 AS JANUARY 27, 2019 BUT SHOULD HAVE BEEN DECEMBER 20, 2018. 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.
PRODUCT COMPLAINT # ==> (B)(4). 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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
PRODUCT COMPLAINT # (B)(4). 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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).
PRODUCT COMPLAINT #: (B)(4). 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 DFA. 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. 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. UDI: (B)(4).
ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE ON 17DECEMBER2018: IT WAS REPORTED THE PROCEDURE WAS AN ACL RECONSTRUCTION. THE SUTURES PULLED OFF THE PLASTIC PART OF DEVICE BEFORE IT COULD BE FULLY PULLED ONTO THE GRAFT. USED THE ARTHREX FIBERLOOP TO COMPLETE PROCEDURE. IT WAS CONFIRMED THERE WAS NO SURGICAL DELAY OR INTERVENTION.
ADDITIONAL INFORMATION RECEIVED ON 11/6/2018. THE SALES REP STATED THAT THE QUANTITY OF THE PRODUCTS INVOLVED IS 4 BUT IT LOOKS LIKE TWO BECAUSE THEY COME IN PACKS OF FOUR. TWO OF EACH PRODUCT CODE FAILED. THE DEVICE STATUS IS DISCARDED. IT WAS REPORTED THAT THE ISSUE WAS DETECTED IMMEDIATELY. THE BONE WAS NOT DAMAGED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT COMPANY'S PRODUCT WITH NO SURGICAL DELAY. THE DEVICE WAS NOT REMOVED/REPLACED IN ANOTHER PROCEDURE. THERE WAS NO SURGICAL INTERVENTION PLANNED.
(B)(4)-INCOMPLETE. THE EXP DATE IS CURRENTLY UNAVAILABLE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING ACL REPAIR, IT WAS OBSERVED THAT THE SURGEON TRIED TO USE SPEED TRAP BUT THE DEVICES MALFUNCTIONED. ACCORDING TO THE REPORT, WHEN THEY WENT TO PULL THE SUTURES ON THE DEVICE, THE LAST WRUNG WOULDN¿T CINCH DOWN, CAUSING THE GRAFT TO BUNCH UP IN AN EFFORT TO PULL THE SUTURE OFF THE LAST WRUNG. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 816103 | SPEEDTRAP WHITE 30MM 4PK | POLYETHYLENE SUTURE | GAT | MEDOS INTERNATIONAL SÃ RL | L193694 | 10886705027163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |