TI LOCKING SCREW
Report
- Report Number
- 8030965-2019-62549
- Event Type
- Injury
- Date Received
- April 5, 2019
- Report Date
- March 13, 2019
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- NKG
- PMA / PMN Number
- K142838
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART NUMBER: 04.614.508, TI LOCKING SCREW; LOT NUMBER: H170008 (NON-STERILE): MANUFACTURING LOCATION: SUPPLIER - GENERAL MACHINE INC. / INSPECTED, PACKAGED AND RELEASED BY: MONUMENT. RELEASE TO WAREHOUSE DATE: 29-SEP-2016. PART NUMBER: 04.614.508, TI LOCKING SCREW. LOT NUMBER: H170008 (NON-STERILE). LOT QUANTITY: 240 . THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PART DHRS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿LOOSENED POSTOPERATIVELY¿ DOES NOT INDICATE BREAKAGE OF THE SCREW. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART NUMBER: 04.614.508, TI LOCKING SCREW; LOT NUMBER: H148652 (NON-STERILE): MANUFACTURING LOCATION: SUPPLIER - GENERAL MACHINE INC. / INSPECTED, PACKAGED AND RELEASED BY: MONUMENT. RELEASE TO WAREHOUSE DATE: 15-SEP-2016. LOT QUANTITY: 244 . THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PART DHRS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿LOOSENED POSTOPERATIVELY¿ DOES NOT INDICATE BREAKAGE OF THE SCREW. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART NUMBER: 04.614.508, TI LOCKING SCREW; LOT NUMBER: H803170 (NON-STERILE): MANUFACTURING LOCATION: SUPPLIER - GENERAL MACHINE INC. / INSPECTED, PACKAGED AND RELEASED BY: MONUMENT. RELEASE TO WAREHOUSE DATE: 30-JAN-2019 . LOT QUANTITY: 241 . THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PART DHRS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿LOOSENED POSTOPERATIVELY¿ DOES NOT INDICATE BREAKAGE OF THE SCREW. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART NUMBER: 04.614.508, TI LOCKING SCREW; LOT NUMBER: H169988 (NON-STERILE): MANUFACTURING LOCATION: SUPPLIER - GENERAL MACHINE INC. / INSPECTED, PACKAGED AND RELEASED BY: MONUMENT . RELEASE TO WAREHOUSE DATE: 16-SEP-2016 . LOT QUANTITY: 244 . THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PART DHRS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿LOOSENED POSTOPERATIVELY¿ DOES NOT INDICATE BREAKAGE OF THE SCREW. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART NUMBER: 04.614.508, TI LOCKING SCREW; LOT NUMBER: H170006 (NON-STERILE): MANUFACTURING LOCATION: SUPPLIER - GENERAL MACHINE INC. / INSPECTED, PACKAGED AND RELEASED BY: MONUMENT. RELEASE TO WAREHOUSE DATE: 03-OCT-2016 . LOT QUANTITY: 241 . THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PART DHRS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿LOOSENED POSTOPERATIVELY¿ DOES NOT INDICATE BREAKAGE OF THE SCREW. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. CUSTOMER QUALITY RETURNED PRODUCT INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL: IT WAS NOT CLARIFIED AT THE TIME OF INVESTIGATION WHICH OF THE SIX RETURNED LOCKING SCREWS WAS THE COMPLAINT DEVICE. THEREFORE, ALL SIX WERE INVESTIGATED. VISUAL INSPECTION: VISUAL INSPECTION OF THE SIX RETURNED DEVICES REVEALED NO DAMAGE TO ANY FEATURE TO ANY OF THE LOCKING SCREWS. FUNCTIONAL TEST: A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE MATING DEVICE WAS NOT RETURNED. DIMENSIONAL INSPECTION: THE MEASUREMENTS OF THE SIX LOCKING SCREW'S MAJOR THREAD DIAMETERS WERE TAKEN AND ALL DIAMETERS WERE WITHIN SPECIFICATION PER RELEVANT DRAWING. DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWING WAS REVIEWED DURING INVESTIGATION. NO DESIGN ISSUES WERE OBSERVED. CONCLUSION: THE COMPLAINT WAS NOT CONFIRMED DURING INVESTIGATION. NO MANUFACTURING ISSUES WERE IDENTIFIED DURING INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED 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. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. 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.
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. UPDATED CONCOMITANT DEVICE LIST ADDITIONAL DEVICE PRODUCT CODES: KWP, MNH, MNI. POTENTIAL LOT NUMBERS: H170008, H148652, H170008, H803170, H169988, H170006. PATIENT CODE 3191 USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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.
DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RETURNED DEVICES IT WAS OBSERVED THAT OCCIPITAL PLATE HAS BROKEN/PEELED THREAD. CONCOMITANT DEVICE REPORTED: OCCIPITAL SCREW (PART # 04.601.110, LOT # 9266553, QUANTITY 1), OCCIPITAL SCREW (PART # 04.601.110, LOT #: 8578433, QUANTITY 1), OCCIPITAL SCREW (PART # 04.601.110, LOT #: L950900, QUANTITY 1), LOCKING SCREW SYNAPSE (PART # 04.614.508, LOT # UNKNOWN, QUANTITY 5). THIS IS REPORT 1 OF 2 FOR (B)(4).
CONCOMITANT DEVICE REPORTED: OCCIPITAL PLATE (PART # 04.615.601, LOT # 1L31217, QUANTITY 1), OCCIPITAL SCREW (PART # 04.601.110, LOT # 9266553, QUANTITY 1), OCCIPITAL SCREW (PART # 04.601.110, LOT #: 8578433, QUANTITY 1), OCCIPITAL SCREW (PART # 04.601.110, LOT #: L950900, QUANTITY 1). THIS REPORT IS FOR ONE (1) TI LOCKING SCREW.
THIS REPORT IS FOR ONE (1) UNKNOWN LOCKING CAP. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. THIS REPORT IS FOR ONE (1) UNKNOWN LOCKING CAP. PMA/510(K) NUMBER IS NOT AVAILABLE. PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019 THAT AN UNKNOWN LOCKING CAP HAS LOOSEN POSTOPERATIVE. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS: ROD (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) UNKNOWN LOCKING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279691 | TI LOCKING SCREW | ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION | NKG | OBERDORF SYNTHES PRODUKTIONS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 4.5MM TI OCCIPITAL SCREW 10MM| OCCIPITAL-PL 4.5/5 MED W/50 F/R Ø4 TI |