10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER
Report
- Report Number
- 2520274-2017-11823
- Event Type
- Injury
- Date Received
- June 19, 2017
- Report Date
- June 2, 2017
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HSB
- PMA / PMN Number
- K011857
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
LOT #¿S FOR CONCOMITANT DEVICES WERE ADDED TO COMPLAINT DESCRIPTION. DEVICE 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.
SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE 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.
PRODUCT DEVELOPMENT & MIA INVESTIGATION WAS COMPLETED. THE INVESTIGATION SUMMARY INDICATES THAT THE: PART #: 456.354S, LOT#: 6550284 (STERILE) - 10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT -STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: 456.314.3 - LOCK DRIVER TFN, BP-55 LOT - 6479328; 456.315.2 - 130 DEGREE LOCK PRONG TFN BP-58 LOT - 6486906. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. THE COMPLAINED TFNA NAIL HAS BEEN FORWARDED TO THE RESPONSIBLE MANUFACTURING SIDE FOR AN EVALUATION. IN THE RECEIPT OF THE INVESTIGATION RESULT, THE LENGTH OF THE NAIL WAS MEASURED WITH A CALIBRATED SCALE AND MEASURED, WHICH MEETS THE SPECIFICATION OF THE TOP-LEVEL DRAWING. THE DIAMETER OF THE NAIL WAS MEASURED WITH A CALIPER AND MEASURED, WHICH MEETS THE SPECIFICATION OF THE TOP-LEVEL DRAWING. THE NAIL WAS UNEVENLY BROKEN AT THE OBLIQUE HOLE, AS WELL AS HAVING THE LOCK PRONG, LOCK DRIVE AND GUIDE SPRING COMPONENTS INSTALLED IN THE HEAD OF THE NAIL; THEREFORE, THE LATERAL BEND ANGLE CANNOT BE MEASURED, NOR OTHER DIMENSIONS ASSOCIATED WITH THE NAIL AT THE PLACE OF THE BREAK. THE AVAILABLE DATA SUPPORTS THE COMPLAINANT¿S DESCRIPTION OF THE COMPLAINT CONDITION OF "NAIL BROKEN" THEREFORE THIS COMPLAINT IS CONFIRMED. HOWEVER, WE CANNOT CONFIRM THE CAUSE OF NAIL BREAKAGE, SO THE COMPLAINT IS UNDERMINED. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC. DEVICE 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.
THIS REPORT IS FOR AN UNKNOWN TFNA NAIL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. ADDITIONAL PRODUCT CODE: HWC. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 PRODUCT CODE: HWC. PART & LOT NUMBER REPORTED. (B)(4). DHR REQUESTED. DEVICE 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 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.
PATIENT¿S HEIGHT REPORTED AS (B)(6) METER. PATIENT¿S IDENTIFIER IS NOT PROVIDED FOR REPORTING. PATIENT¿S DATE OF BIRTH IS REPORTED AS (B)(6) 1932; EXACT DATE IS UNKNOWN. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, 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. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 15-DEC-2010; EXPIRATION DATE: 31-DEC-2020. PART #: 456.354S, LOT#: 6550284 (STERILE) - 10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT - STERILE. QUANTITY 6. IN-PROCESS INSPECTION SHEET FINAL INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 456.314.3 - LOCK DRIVER TFN, BP-55 LOT - 6479328; 456.315.2 - 130 DEGREE LOCK PRONG TFN, BP-58 LOT - 6486906; 21069 - RAW MATERIAL, LOT BP-80, LOT - 6318045. 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. SCN NO: 7278, ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ RECALL NOTIFICATION NUMBER. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
UPDATE: LOT NUMBER'S ADDED TO CONCOMITANT DEVICES: 1X 456.307S - HELICAL BLADE F/TFN, Ø 11.0MM, L 110MM, LOT # 6683583, 1X 459.420 - LOCKING BOLT Ø 4.9MM, SELF-TAPP, L 42MM, LOT # 5915641, 1X 459.380 - LOCKING BOLT Ø 4.9MM, SELF-TAPP, L 38MM, LOT # 5912696.
UPDATE 15DEC17: CONCOMITANT DEVICES: 1X 456.307S - HELICAL BLADE F/TFN, Ø 11.0MM, L 110MM. 1X 459.420 - LOCKING BOLT Ø 4.9MM, SELF-TAPP., L 42MM. 1X 459.380 - LOCKING BOLT Ø 4.9MM, SELF-TAPP., L 38MM.
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PROXIMAL FEMORAL NAIL (TFNA) BROKE POSTOPERATIVELY. THE BREAKAGE OCCURRED THREE TO FIVE (3-5) MONTHS AFTER IMPLANT SURGERY. NO INFORMATION ABOUT PATIENT STATUS WAS PROVIDED. THIS REPORT IS FOR AN UNKNOWN TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).
THE NAIL BROKE POSTOPERATIVELY AT THE LEVEL OF THE BLADE HOLE.
FURTHER IT WAS REPORTED THAT THE PATIENT WAS INITIALLY IMPLANTED WITH A PROXIMAL FEMORAL NAIL (TFNA) ON (B)(6) 2017 AND WAS REVISED ON (B)(6) 2017. CONCOMITANT DEVICE REPORTED: BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432137 | 10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER | ROD,FIXATION,INTRAMEDULLARY | HSB | SYNTHES MONUMENT | 6550284 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |