2.4MM TI VA LOCKING SCREW STARDRIVE 12MM-STERILE
Report
- Report Number
- 8030965-2018-53178
- Event Type
- Malfunction
- Date Received
- April 17, 2018
- Date of Event
- March 29, 2018
- Report Date
- March 29, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HRS
- UDI-DI
- 07611819980631
- PMA / PMN Number
- K102694
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ADDED CONCOMITANT DEVICE. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: PART NO.: 04.210.112S, LOT NO.: L595509: MANUFACTURING LOCATION: SELZACH, SUPPLIER: FRUEH AG, RELEASE TO WAREHOUSE DATE: 02.OCT.2017, EXPIRY DATE: 01.SEP.2027: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE 04.210.112 / H415112WAS MANUFACTURED IN US, MONUMENT: MANUFACTURING LOCATION: SUPPLIER MARK TWO ENGINEERING, INC. PACKAGED BY: MONUMENT FOR EU, MANUFACTURING DATE: 05-SEP-2017: PART NO: 04.210.112, LOT NO: H415112 (NON-STERILE) - 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM. QUANTITY 240. COMPONENTS REVIEWED: RAW MATERIAL PART 21015 LOT 9954218 MEET SPECIFICATION. RAW MATERIAL RECEIVED FROM SUPPLIER PERRYMAN COMPANY. CERTIFIED TEST REPORT RECEIVED FROM PERRYMAN FOR TITANIUM INGOT MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR FINAL INSPECTION MEET INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE FOR TI RECEIVED FROM MARK TWO ENGINEERING, INC. MEET SPECIFICATION. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. ONLY ONE VA LOCKING SCREW WAS RETURNED FOR INVESTIGATION; THE DRILL GUIDE AND THE PLATE WAS NOT RETURNED. THE VISUAL INSPECTION HAS SHOWN THAT THE SCREW IN QUESTION PRESENTS SOME HEAVY WEAR MARKS ON THE THREAD OF THE SCREW HEAD AS WELL AS ON THE THREAD OF THE SCREW SHAFT. THE FLANKS OF THE THREADS ARE ROUNDED AND FLATTENED. THE ANODIZED ROSE RED COLOR IS ABRADED IN ALL AFFECTED AREAS. THE REVIEW OF THE PRODUCTION HISTORIES REVEALED THAT THIS LOCKING SCREW WAS MANUFACTURED IN OCTOBER 2017 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. THE CERTIFICATE OF THE RAW MATERIAL HAS BEEN REVIEWED AND INDICATES THAT MATERIAL CONFORMS TO SPECIFICATIONS. WE ARE NOT AWARE OF ANY QUALITY ISSUES WITH THIS ART/ LOT NUMBER. THE RELEVANT DIMENSIONS COULD NOT BE CHECKED DUE TO THE DAMAGE INCURRED. THE CONDITION OF THE SCREW THREAD INDICATES THAT IT GOT DAMAGED BECAUSE OF CROSS-THREADING OR FORCIBLE USE DURING INSERTION. THIS CONCLUSION IS ALSO SUPPORTED BY THE STATEMENT GIVEN BY THE SURGEON THAT THE DIRECTION OF THE SCREW DURING INSERTION AND/OR THE PLACING OF THE DRILL GUIDE MIGHT NOT BE APPROPRIATE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE 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.
CONCOMITANT DEVICE REPORTED UNKNOWN TRAUMA SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN).
PATIENT DATE OF BIRTH AND WEIGHT NOT AVAILABLE FOR REPORTING. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR DISTAL RADIUS FRACTURES ON (B)(6) 2018. SURGEON HAD DIFFICULTY IN INSERTING A VARIABLE ANGLE (VA) LOCKING SCREW. SCREW INSERTION WAS COMPLETED BUT SURGEON WAS NOT ABLE TO LOCK THE VA LOCKING SCREW. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 30 MINUTES. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. SURGEON STATED A GAP AROUND THE VA LOCKING SCREW WAS NOTED. HOWEVER, THE OTHER SCREWS WERE SECURED. IT WAS ALSO NOTED BY THE SURGEON THAT THE DIRECTION OF THE SCREW INSERTION MAY NOT HAVE BEEN PROPER, SELF-TAPPING OF THE SCREW WAS NOT EFFECTIVE. BECAUSE THE INCISION WAS A LITTLE SMALLER, EXTRA TENSION MAY HAVE ADVERSELY AFFECTED SETTING OF THE DRILL GUIDE TO THE PLATE AND THE SCREW INSERTION. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW 12MM. THIS IS REPORT 1 OF 3 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280586 | 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM-STERILE | PLATE, FIXATION, BONE | HRS | OBERDORF SYNTHES PRODUKTIONS GMBH | L595509 | 07611819980631 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |