TRUESPAN 12 DEGREE PEEK
Report
- Report Number
- 1221934-2018-54926
- Event Type
- Malfunction
- Date Received
- October 11, 2018
- Date of Event
- January 1, 2018
- Report Date
- October 18, 2018
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL
- Product Code
- MBI
- UDI-DI
- 10886705026012
- PMA / PMN Number
- K153667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # (B)(4). 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). 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 # PC-(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). INCOMPLETE THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE.
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). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE.
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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THERE WERE FOUR COMPLAINT DEVICES REPORTED THAT WERE USED DURING ONE PROCEDURE. THREE OF THE DEVICES WERE FROM THE SAME LOT AND THE 4TH DEVICE WAS FROM A DIFFERENT LOT. THE FOUR DEVICES WERE RECEIVED, AND AN EVALUATION WAS PERFORMED ON EACH DEVICE. THERE IS NO LOT NUMBER ON THE DEVICES, THEREFORE WE CANNOT IDENTIFY WHICH ONES ARE FROM WHICH OF THE TWO LOTS REPORTED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR BOTH PRODUCT LOT NUMBER COMBINATIONS; PRODUCT CODE 228151/ LOT # L915368 (QTY 3) AND PRODUCT CODE 228151/ LOT # L982352. NO NON-CONFORMANCES WERE IDENTIFIED FOR EITHER ONE. THERE WERE PICTURES OF THE DEVICES PROVIDED AFTER THE REPORTED FAILURE. THE DEVICES WERE EVALUATED AND THE EVALUATIONS OF THE FOUR DEVICES ARE AS FOLLOWS: DEVICE 1 OF 4 . VISUAL OBSERVATIONS REVEALED BOTH THE IMPLANTS GOT STUCK AT THE DISTAL END OF WHITE SLEEVE STOP TUBE OF THE DEVICE. THIS COMPLAINT CAN BE CONFIRMED. THE SHAFT IS SLIGHTLY BENT/DEFORMED NEAR THE DISTAL END OF THE DEVICE. BOTH IMPLANTS WERE INTACT AND LINKED TOGETHER WITH THE SUTURE, NO ANOMALIES WERE FOUND ON THE IMPLANTS. THE PUSHER ROD WAS EVALUATED, VIA FUNCTIONAL TESTING THE TRIGGER WAS PULLED. A CLICK WAS HEARD, INDICATING THE PUSHER ROD BY ITSELF WAS FUNCTIONAL. ONE OF THE POSSIBLE ROOT CAUSES FOR THE REPORTED FAILURE IS USER TECHNIQUE IN APPLYING THE DEVICE WITH TOO MUCH FORCE, BUT DUE TO THE CURRENT CONDITION OF THE DEVICE WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. DEVICE 2 OF 4 . FROM THE PICTURE PROVIDED, IT IS SHOWN THAT BOTH THE IMPLANTS GOT STUCK AT THE DISTAL END OF WHITE SLEEVE STOP TUBE OF THE DEVICE BUT WHEN THE DEVICE WAS VISUALLY OBSERVED THE TWO IMPLANTS HAVE FELL APART FROM THE DEVICE ALONG WITH THE SUTURE. THIS COMPLAINT CAN BE CONFIRMED. BOTH IMPLANTS WERE INTACT AND LINKED TOGETHER WITH THE SUTURE, NO ANOMALIES WERE FOUND ON THE IMPLANTS. THE PUSHER ROD WAS EVALUATED, VIA FUNCTIONAL TESTING THE TRIGGER WAS PULLED. A CLICK WAS HEARD, INDICATING THE PUSHER ROD BY ITSELF WAS FUNCTIONAL. ONE OF THE POSSIBLE ROOT CAUSES FOR THE REPORTED FAILURE IS USER TECHNIQUE IN APPLYING THE DEVICE WITH TOO MUCH FORCE, BUT DUE TO THE CURRENT CONDITION OF THE DEVICE WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. DEVICE 3 OF 4 . VISUAL OBSERVATION REVEALS THAT BOTH THE IMPLANTS WERE NOT RETURNED AND THERE WERE NO ANOMALIES ON THE DEVICE. THE COMPLAINT CAN BE CONFIRMED. THE PUSHER ROD WAS EVALUATED, VIA FUNCTIONAL TESTING THE TRIGGER WAS PULLED. A CLICK WAS HEARD, INDICATING THE PUSHER ROD BY ITSELF WAS FUNCTIONAL. ONE OF THE POSSIBLE ROOT CAUSES FOR THE REPORTED FAILURE IS USER TECHNIQUE IN APPLYING THE DEVICE WITH TOO MUCH FORCE, BUT DUE TO THE CURRENT CONDITION OF THE DEVICE WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. DEVICE 4 OF 4. VISUAL OBSERVATION REVEALS THAT BOTH THE IMPLANTS WERE NOT RETURNED AND THERE WERE NO ANOMALIES ON THE DEVICE. THE COMPLAINT CAN BE CONFIRMED. THE PUSHER ROD WAS EVALUATED, VIA FUNCTIONAL TESTING THE TRIGGER WAS PULLED. A CLICK WAS HEARD, INDICATING THE PUSHER ROD BY ITSELF WAS FUNCTIONAL. ONE OF THE POSSIBLE ROOT CAUSES FOR THE REPORTED FAILURE IS USER TECHNIQUE IN APPLYING THE DEVICE WITH TOO MUCH FORCE, BUT DUE TO THE CURRENT CONDITION OF THE DEVICE WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. 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).
ADDITIONAL INFORMATION RECEIVED ON 9/19/2018. A SURGICAL DELAY OF 10 MINUTES WAS REPORTED. THE SURGERY WAS COMPLETED WITH THE SAME LIKE PRODUCT. THE DEVICES WERE AVAILABLE FOR RETURN. DEVICES WERE FIRED WITH FORCE. TWO IMPLANTS WERE DEPLOYED AT THE SAME TIME. ADDITIONAL INFORMATION RECEIVED ON 9/24/2018. IT WAS REPORTED THAT THE TOTAL 4 PRODUCTS LISTED AS IMPACTED PRODUCTS (LOT L915368, QTY 3; LOT L982352, QTY 1) EXPERIENCED FAILURES OF DOUBLE DEPLOYMENT.
(B)(4)-INCOMPLETE. THE LOT NUMBER IS CURRENTLY UNAVAILABLE; THEREFORE, THE EXP DATE IS 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 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO TRUESPAN 12 DEGREE PEEK DEVICES DID NOT TRIGGER. 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 |
|---|---|---|---|---|---|---|---|
| 795886 | TRUESPAN 12 DEGREE PEEK | SOFT-TISSUE ANCHOR, BIOABSORBABLE | MBI | MEDOS INTERNATIONAL SÃ RL | UNK | 10886705026012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |