TI SPIRAL BLADE 65MM FOR TI RETROGRADE FEMORAL NAILS-EX
Report
- Report Number
- 8030965-2018-53069
- Event Type
- Injury
- Date Received
- April 12, 2018
- Report Date
- March 19, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- UDI-DI
- 10886982087447
- PMA / PMN Number
- K033618
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PE
- Reporter Occupation
- HEALTH 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 REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE. PART NUMBER: 04.013.045 , LOT NUMBER: H111106 , DATE OF MANUFACTURE: 26 MAY 2016 , PLACE OF MANUFACTURE: ELMIRA , NONCONFORMANCE NOTED: N/A . DESCRIPTION OF DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TI SPIRAL BLADE 65MM FOR TI RETROGRADE FEMORAL NAILS ¿ EX NONSTERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL 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. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: DEVICE EVALUATION: INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL VISUAL INSPECTION: THE SPIRAL BLADE WAS RECEIVED WITH INTACT WITH SURFACE WEAR CONSISTENT WITH IMPLANT AND REMOVAL. NO DEFECTS WHICH WOULD IMPACT THE COMPLAINT CONDITION WERE OBSERVED. FUNCTIONAL TEST: A FUNCTIONAL TEST COULD NOT BE COMPLETED AS THE MATING NAIL WAS NOT RETURNED. BASED ON THE VISUAL AND FUNCTIONAL INSPECTION, THE RECEIVED CONDITION DOES NOT AGREE WITH THE COMPLAINT DESCRIPTION AS NO DEFECTS WERE IDENTIFIED ON THE DEVICE AND NO MEDICAL IMAGING WAS PROVIDED SHOWING THE MIGRATION. ADDITIONALLY, THE COMPLAINT CONDITION CANNOT BE REPLICATED AS THE MATING NAIL WAS NOT RETURNED. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED; SPIRAL BLADE. THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION SINCE THE ONLY DESIGN REVISION SINCE THE DATE OF MANUFACTURE CONCERNS THE ETCHING ON THE DEVICE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DIMENSIONAL INSPECTION: THE OVERALL LENGTH MEASURED 65.03MM WHICH IS WITHIN THE SPECIFICATION OF 65MM +/- 0.3 PER DRAWING AND ISO 02768-1 1ST EDITION 1989-11-15. MEASURED USING CALIPERS CA814. THE BLADE WIDTH MEASURED (12.41MM/12.38MM) WHICH IS WITHIN THE SPECIFICATION OF 12.5MM +0/-0.2 PER DRAWING. MEASURED USING CALIPERS CA814. RISK ASSESSMENT REVIEW: THE R/AFN - EXPERT RETROGRADE/ANTEGRADE FEMORAL NAIL DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. CONCLUSION: IN CONCLUSION, THE COMPLAINT CONDITION IS UNCONFIRMED AS NO PRODUCT DEFECT WAS IDENTIFIED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS CIRCUMSTANCES SURROUNDING THE EVENT AND OVER THE DURATION OF IMPLANT ARE UNKNOWN. HOWEVER, NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION. THE RISK ASSESSMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. NO MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. 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.
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. ADDITIONAL NARRATIVE: UPDATE EVENT DESCRIPTION AND CONCOMITANT DEVICES INITIAL REPORTER TITLE, NAME, COUNTRY CODE, OCCUPATION DATE OF MANUFACTURE 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 PERU AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT AN ANKLE ARTHRODESIS PROCEDURE ON UNKNOWN DATE IN FEBRUARY 2018. POST-OPERATIVE X-RAYS TAKEN ON UNKNOWN DATE REVEALED THE SPIRAL BLADE HAD MIGRATED. PATIENT REPORTED NO FALL AFTER THE INITIAL PROCEDURE. REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY ON MARCH 16, 2018. PATIENT REPORTED AS STABLE POST-OPERATIVELY. CONCOMITANT DEVICE REPORTED: TITANIUM END CAP T25 STARDRIVE HINDFOOT ARTHRO NAIL-EX SPIRAL BLADE (04.008.000, LOT H414107, QUANTITY 1) THIS REPORT IS FOR ONE (1) TITANIUM SPIRAL BLADE 65MM FOR RETROGRADE FEMORAL NAILS-EX THIS IS REPORT 1 OF 1 FOR (B)(4).
ADDITIONAL CLASSIFICATION CODE: HWC. IMPLANT DATE IS UNKNOWN. IT WAS IN (B)(6) 2018. (B)(6). A DEVICE HISTORY RECORD REVIEW WAS REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PATIENT CODE: (B)(4) SURGICAL INTERVENTION--THE SPIRAL BLADE MIGRATED POSTOPERATIVELY REQUIRING REVISION SURGERY. 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.
ADDITIONAL NARRATIVE: 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AFTER THE PATIENT WAS OPERATED A MONTH AGO FOR AN ANKLE ARTHRODESIS, THE SPIRAL BLADE MIGRATED TO ANOTHER PLACE FROM THE NORMAL LOCATION. THE DEVICE MIGRATED WAS IDENTIFIED FROM POST OP X-RAYS. THE PATIENT REPORTS NO FALLS AFTER ORIGINAL PROCEDURE. ORIGINAL PROCEDURE WAS PERFORMED IN (B)(6) 2018 AND PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT WAS REPORTED AS STABLE POST-OPERATIVELY. THE EXPLANT OPERATION OF SPIRAL BLADE WAS (B)(6) 2018. THIS IS REPORT 1 OF 1 FOR (B)(4).
FURTHER IT WAS REPORTED THAT THE SPIRAL BLADE AND TI END CAP T25 HIND FOOT WAS EXPLANTED WITH NO ALLEGATION AGAINST TI END CAP T25 HIND FOOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269289 | TI SPIRAL BLADE 65MM FOR TI RETROGRADE FEMORAL NAILS-EX | ROD,FIXATION,INTRAMEDULLARY | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | 04.013.045 | H111106 | 10886982087447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |