3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/RT/123MM
Report
- Report Number
- 8030965-2019-64225
- Event Type
- Injury
- Date Received
- May 21, 2019
- Report Date
- April 23, 2019
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HRS
- PMA / PMN Number
- K111540
- 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. 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. PART 04.112.018, LOT H770679: PART MANUFACTURING DATE: NOVEMBER 07, 2018. MANUFACTURING SITE: ELMIRA. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2.7MM/3.5MM TI LCP SUPERIOR ANTERIOR CLAVICLE PLATE WITH LATERAL EXTENSION 7 HOLES /RIGHT/123MM NONSTERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: THE VISUAL INSPECTION OF THE LCP PLATE HAS SHOWN THAT THERE ARE THREE LOCKING SCREW HEADS ARE JAMMED IN THE THREADED HOLES ON LATERAL SIDE. THE ARTICLE IS IN USED CONDITION. UPON VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION WITH THE BROKEN SCREWS, THE BROKEN SCREW HEADS ARE STILL LOCKED IN THE PLATE WHICH SHOWS THAT THE LOCKING FUNCTION WAS FUNCTIONAL AS REQUIRED. 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. H3, H6: THE DEVICE WAS 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.
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.
IT WAS CLARIFIED THAT THE PLATE ITSELF WAS NOT BROKEN. ONLY THE SCREWS WERE BROKEN.
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT IMPLANT REMOVAL DUE TO FRACTURE OF THE LOCKING COMPRESSION PLATE (LCP) SUPERIOR ANTERIOR CLAVICLE PLATE AND THE FOUR (4) BROKEN LOCKING SCREWS. PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: LOCKING SCREW (PART: 413.020, LOT: L810809, QUANTITY: 1), LOCKING SCREW (PART: 413.018, LOT: 2L41785, QUANTITY: 1), LOCKING SCREW (PART: 413.014, LOT: 2L14082, QUANTITY: 1), CORTEX SCREW (PART: 404.818, LOT: 3L19002, QUANTITY: 1). THIS REPORT IS FOR A 3.5MM TITANIUM (TI) LCP SUPERIOR ANTERIOR CLAVICLE PLATE.
THIS IS REPORT 1 OF 4 FOR (B)(4).
BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR, LOT #, PART #, UDI #, 510K: THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR, MANUFACTURE DATE: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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. (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.
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT IMPLANT REMOVAL DUE TO FRACTURE OF THE PLATE. PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421147 | 3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/RT/123MM | PLATE, FIXATION, BONE | HRS | OBERDORF SYNTHES PRODUKTIONS GMBH | H770679 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 3.5MM TI LOCKING SCREW SELF-TAPPING 14MM| 3.5MM TI LOCKING SCREW SELF-TAPPING 18MM| 3.5MM TI LOCKING SCREW SELF-TAPPING 20MM| CORTSCR Ø3.5 SELF-TAP L18 TI| UNK - SCREWS: TRAUMA| UNK - SCREWS: TRAUMA |