10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
Report
- Report Number
- 2939274-2019-57232
- Event Type
- Injury
- Date Received
- April 3, 2019
- Report Date
- March 11, 2019
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HSB
- UDI-DI
- 10886982096005
- PMA / PMN Number
- K160167
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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 HISTORY LOT: MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: 25-JUL-2016. EXPIRATION DATE: 30-JUN-2026. PART NUMBER: 04.037.044S, 10MM/130 DEG TI CANN TFNA 235MM/RIGHT : STERILE. LOT NUMBER: H151374 (STERILE) . LOT QUANTITY: (B)(4). ONE PIECE WAS SCRAPPED IN CELL AT OP #20, MILL ID, FOR A DIMENSIONAL FAILURE OF THE COUNTERBORE. THE REMAINING FIVE PIECES WERE 100% INSPECTED AND FOUND TO BE ACCEPTABLE FOR THIS DIMENSION. THIS LOT WAS PROCESSED UNDER PLANNED NR-0044653. THIS WAS A PLANNED NON CONFORMANCE FOR JBS#103259876 AND JBS#103259869. JBS#103259876 REV 1 OMITS THE REQUIREMENT TO ADD DUNNAGE TO THE MAILER AT THE BOXING OPERATION FOR ORDERS THAT ARE NOT FULL LOTS. BOXING PROCESS SHEET PS062955 REV K CONTRADICTS JBS#103259876 REV 1 AND REQUIRES THE OPERATOR TO ADD DUNNAGE TO THE MAILER AFTER THE PARTS HAVE BEEN SHRINK WRAPPED AT THE BOXING OPERATION. JBS#103259869 REV 1 INCORRECTLY REQUIRES THE OPERATOR TO ADD DUNNAGE AT SHIPPING. PER PROCESS SHEET PS062955 REV K, THIS IS PERFORMED AT THE BOXING OPERATION AND NOT AT THE SHIPPING OPERATION. THIS PLANNED NC WILL ENSURE ALL LOTS GOING THROUGH BOXING WILL REPEAT STEPS 3.08 AND 3.09 IN JBS#103259876 AND DUNNAGE WILL BE ADDED TO THE REQUIRED LOTS PER PS062955 REV K AT THE BOXING OPERATION AND NOT AT SHIPPING. THIS PLANNED NR WOULD NOT HAVE CONTRIBUTED TO THE REPORTED COMPLAINT CONDITION OF ¿NAIL BREAKAGE AT THE JUNCTION OF THE HELICAL BLADE¿. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. INSPECTION SHEET, IN PROCESS / INSPECT DIMENSIONAL / FINAL, NS063030 REV E MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION, NS067861 REV A MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF, LMD/LPF REV C WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN 12774 SUPPLIED BY EES (ALBUQUERQUE) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PARTS REVIEWED: PART NUMBER: 04.037.942.2, LOCK PRONG, 130 DEGREE, TFNA BP55. LOT NUMBER: L028044. LOT QUANTITY: (B)(4). PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED BP55. LOT NUMBER: H045956. LOT QUANTITY:(B)(4). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, NS062851 REV B MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATION AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD SUPPLIED BY SMALLEY DATED 18-MAY-2016 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE BP58. LOT NUMBER: H132034. LOT QUANTITY: (B)(4). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET NS062925 REV D MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMO AGRI 16.00 BP80. LOT NUMBER: H062002. LOT QUANTITY: (B)(4) LBS. CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS INC. DATED 23-FEB-2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 16-MAR-2016 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW 21-MAR-2019: DHR, THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IT WAS REPORTED THAT ON MARCH 11, 2019, DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) SURGERY, A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) NAIL FAILED AND BROKE AT THE JUNCTION OF THE HELICAL BLADE. RESULTING IN A REVISION SURGERY TO REMOVE THE BROKEN NAIL AND IMPLANTED A LONG NAIL AND HAD A BONE GRAFT. THE ORIGINAL IMPLANTATION WAS ON (B)(6) 2018. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # (B)(4)), UNK - NAIL HEAD ELEM: TFNA HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # (B)(4)), UNK - END CAPS: TFNA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # (B(4)). THIS COMPLAINT INVOLVES ONE (1) DEVICE. US CUSTOMER QUALITY INVESTIGATION FLOW: BROKEN. VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF POSTOPERATIVE BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THE NAIL BROKE AT THE PROXIMAL HOLE. THE BREAK IS JAGGED AND OBLIQUE. BOTH NAIL PORTIONS WERE RETURNED. DHR REVIEW: THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW: NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. DIMENSIONAL INSPECTION: THE OUTSIDE DIAMETER OF THE RETURNED NAIL NEAR BREAKAGE IS WITHIN SPECIFICATION. THE INSIDE DIAMETER OF THE RETURNED NAIL NEAR BREAKAGE IS WITHIN SPECIFICATION. MATERIAL REVIEW: CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS INC. DATED 23-FEB-2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 16-MAR-2016 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. INVESTIGATION CONCLUSION: A DEFINITIVE ASSIGNABLE ROOT CAUSE FOR THE NAIL BREAKING POSTOPERATIVELY COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION AND THIS COMPLAINT CONDITION IS ADEQUATELY COVERED BY THE RISK ASSESSMENT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. 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.
OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. 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.
IT WAS REPORTED THAT ON (B)(6) 2018, AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) SURGERY WAS PERFORMED. THE TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) NAIL FAILED AND BROKE AT THE JUNCTION OF THE HELICAL BLADE. THIS RESULTED IN A REVISION SURGERY ON (B)(6) 2019, TO REMOVE THE BROKEN NAIL AND IMPLANT A LONG NAIL. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNK - NAIL HEAD ELEM: TFNA HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNK - END CAPS: TFNA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271012 | 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE | ROD, FIXATION, INTRAMEDULLARY | HSB | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 04.037.044S | H151374 | 10886982096005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |