11MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
Report
- Report Number
- 2520274-2015-17779
- Event Type
- Injury
- Date Received
- December 10, 2015
- Report Date
- November 19, 2015
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HSB
- PMA / PMN Number
- PK131548
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
(B)(6). COMPLAINANT PART 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.
(B)(6). (B)(4). DEVICE NOT REPORTEDLY EXPLANTED. 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.
DATE OF EVENT IS UNKNOWN. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.037.144S, LOT# 7930752. MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: APR 17, 2015, EXPIRY DATE: MAR 31, 2025. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED BASED ON THE PROVIDED PICTURES. D ALTHOUGH NO DEVICES WERE RETURNED TO MANUFACTURER, VISUAL EVIDENCE (PHOTOS) OF THE BROKEN NAIL WAS PROVIDED. THE TRANSVERSE BREAK ON THE NAIL OCCURRED IN THE MIDDLE OF THE PROXIMAL LOCKING HOLE FOR FEMORAL HEAD ELEMENT. A DIMENSIONAL INSPECTION OF FEATURE(S) RELATED TO THIS COMPLAINT COULD NOT BE PERFORMED AS THE NAIL WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. RELEVANT DRAWINGS WERE REVIEWED. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME AS NO DEVICES WERE RETURNED FOR EVALUATION AND 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. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. CORRECTED DATA: PART#, LOT# AND (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.
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 DUE TO NON-UNION. THE SURGERY WAS DELAYED THIRTY TO FORTY-FIVE (30-45) MINUTES DUE TO DIFFICULTY REMOVING THE TFN-A WHICH HAD BROKEN AT THE HELICAL BLADE HOLE. THE SURGEON USED VICE GRIPS TO REMOVE THE NAIL AND EXTRACTED ALL PIECES AND HARDWARE: TFN-A, HELICAL BLADE AND LOCKING SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS REVISED TO A SYNTHES 95 DEGREE BLADE PLATE. IT WAS REPORTED THAT THE PATIENT WAS STABLE.
IT WAS REPORTED THAT A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) ORIGINALLY IMPLANTED ON (B)(6) 2015 WAS FOUND TO BE BROKEN POSTOPERATIVELY. ON OR ABOUT (B)(6) 2015, THE PATIENT WAS WALKING IN THEIR YARD AND FELT A PAINFUL "POP" IN HIS HIP. DURING A FOLLOW-UP VISIT WITH THE SURGEON ON (B)(6) 2015, X-RAYS REVEALED THE TFNA HAD BROKEN THROUGH THE HELICAL BLADE HOLE. X-RAYS ALSO SHOWED THAT THE FRACTURE HAD MOSTLY HEALED. IN ADDITION, THE PATIENT WAS REPORTEDLY EXPERIENCING LESS PAIN THAN WHEN THEY FELT THE INITIAL "POP". IT WAS REPORTED THAT A DECISION WILL BE MADE IN (B)(6) 2016 REGARDING A REVISION. THIS IS REPORT 1 OF 1 FOR (B)(4).
IT WAS FURTHER REPORTED THAT ON (B)(6) 2015 PATIENT HAD A 3-PART INTERTROCHANTERIC DISPLACED FRACTURE OF HIS RIGHT HIP. POST OPERATIVELY, ON (B)(6) 2015, PATIENT REPORTED PAIN IN HIS HIP AS BURNING, SHARP, THROBBING, DULL. ON (B)(6) 2016, PATIENT DESCRIBED AGAIN PAIN AS ACHING, DEEP, DULL. ON (B)(6) 2016, PATIENT EXPERIENCED PAIN AS ACHING, DEEP AND DULL. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 DUE TO NON-UNION. ON (B)(6) 2016, PROCEDURE WAS COMPLICATED DUE TO THE FACT AN INTRAMEDULLARY NAIL WAS BROKEN. THE DISTAL ASPECT OF THE NAIL WAS TOO NARROW TO ACCEPT MULTIPLE BALL-TIP GUIDEWIRES AND THE SITE REQUIRED THREADING AN EXTRACTION ROD INTO THE PROXIMAL ASPECT OF THE BROKEN NAIL AND EXTRACTING IT. THIS ADDED APPROXIMATELY 1 HOUR OF ADDITIONAL OPERATING ROOM TIME. REMOVAL OF THE BROKEN NAIL REQUIRED A SIGNIFICANT AMOUNT OF TIME AND TRIAL WITH MANY, MULTIPLE INSTRUMENTS. AFTER REMOVAL OF THE BROKEN TFNA DEVICE, THE BONE GRAFT PROCEDURE WAS PERFORMED AND A BLADE PLATE WAS SECURED TO THE FEMUR WITH CORTICAL SCREWS. CONCOMITANT DEVICES REPORTED: 3.0MM REAMING ROD/950MM W/STRAIGHT BALL TIP - STERILE (PART # 351.76S , LOT # 7871437, QUANTITY # UNKNOWN), TFNA HELICAL BLADE 105MM STERILE (PART # 04.038.305S, LOT # 7955389, QUANTITY # 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS (PART # 04.005.528, LOT # UNKNOWN, QUANTITY # 1).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 814383 | 11MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE | ROD, FIXATION, INTRAMEDULLARY | HSB | SYNTHES MONUMENT | 7930752 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |