BLUNT TIP SCREW, 4X44MM
Report
- Report Number
- 0009613350-2021-00334
- Event Type
- Injury
- Date Received
- July 6, 2021
- Report Date
- September 23, 2021
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- HSB
- UDI-DI
- 00889024505469
- PMA / PMN Number
- K200814
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT ON (B)(6) 2021 AND REVISED ON AN UNKNOWN DATE AT THE END OF MAY DUE TO MIGRATION. AFTER 1 MONTH FROM THE INITIAL SURGERY, THE #2 BLUNT TIP SCREW WAS GRADUALLY MIGRATED FROM THE PROPER POSITION. ONLY THE #2 WAS EXPLANTED IN THE REVISION SURGERY. REVIEW OF RECEIVED DATA: DUE DILIGENCE: FURTHER "DUE DILIGENCE" TO SUPPORT THE CONCLUSION WAS COMPLETED AND DOCUMENTED IN DILIGENCE LOG. X-RAYS: TWO X-RAY IMAGES HAVE BEEN PROVIDED AND HAVE BEEN EVALUATED BY AN HCP. TWO IMAGES OF LEFT HUMERUS WITH INTRAMEDULLARY NAIL: IMAGE 1: FRONTAL VIEW WITH THE ELBOW EXTENDED IMAGE 2: FRONTAL VIEW FOREARM EXTERNALLY ROTATED BOTH OF THE IMAGES DEMONSTRATE INTRAMEDULLARY NAIL WITHIN THE HUMERUS AND AN OBLIQUELY ORIENTED, NONUNITED FRACTURE OF THE PROXIMAL TO MID DIAPHYSIS OF THE HUMERUS. NO SIGNIFICANT CALLUS DEVELOPMENT IS SEEN ON EITHER OF THE IMAGES. ASSESSMENT OF IMAGING: ON IMAGE 1, THERE APPEAR TO BE 4 SCREWS, WITH 1 OF THE MID SCREWS APPEARING BACKED OUT WITH RESPECT TO THE LATERAL CORTEX OF THE HUMERAL HEAD. THE REMAINING SCREWS APPEAR TO BE APPROPRIATELY POSITIONED WITH THE HEADS OF THE SCREWS CLOSELY APPROXIMATED TO THE LATERAL CORTEX OF THE HUMERAL HEAD. ON IMAGE 2, THERE ARE LIKELY 3 SCREWS WHICH ARE APPROPRIATELY POSITIONED WITH THE HEADS OF THE SCREWS CLOSELY APPROXIMATED TO THE LATERAL CORTEX OF THE HUMERAL HEAD. IMPRESSIONS: INTRAMEDULLARY NAIL WITH NON HEALED PERIPROSTHETIC FRACTURE OF THE PROXIMAL HUMERUS, POTENTIALLY PRESENT PRIOR TO THE HARDWARE PLACEMENT AND SEEN ON BOTH IMAGES PROVIDED. ON IMAGE 1, THERE IS A BACKED OUT SCREW WHICH APPEARS TO HAVE BEEN REMOVED BY THE IMAGE 2 TIME POINT. EXACT CHRONOLOGY OF SEQUENCE OF EVENTS IS DIFFICULT TO CONFIRM GIVEN THAT NO TIME POINTS HAVE BEEN PROVIDED. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RAW MATERIAL CERTIFICATE: THE RAW MATERIAL CERTIFICATE WAS REVIEWED WITH NO ANOMALIES NOTED. SURGICAL TECHNIQUE SAP: THE SURGICAL TECHNIQUE 197-GLBL-EN EXPLAINS THAT THE LOCKING OF THE CORELOCK IS DONE USING THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. "TURN SLOWLY CLOCKWISE TO TIGHTEN AND ENGAGE THE CORELOCK MECHANISM UNTIL A CLICK IS FELT FROM THE TORQUE LIMITING HANDLE." CONCLUSION: IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT ON (B)(6) 2021 AND REVISED ON AN UNKNOWN DATE AT THE END OF MAY DUE TO MIGRATION. AFTER 1 MONTH FROM THE INITIAL SURGERY, THE #2 BLUNT TIP SCREW WAS GRADUALLY MIGRATED FROM THE PROPER POSITION. ONLY THE #2 WAS EXPLANTED IN THE REVISION SURGERY. IT WAS ALSO REPORTED THAT THE TORQUE DRIVER WAS USED TO ENGAGE THE CORELOCK, FURTHERMORE NON-TORQUE DRIVER WAS USED TO TIGHTEN MORE AFTER USING THE TORQUE DRIVER. NO PRODUCT WAS RETURNED, HENCE VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED; THEREFORE, THE CONDITION OF THE PART(S) IS UNKNOWN. TWO X-RAY IMAGES WERE PROVIDED AND ASSESSED BY HCP. THE REPORTED EVENT WAS CONFIRMED, BUT NO CONTRIBUTING FACTORS WERE IDENTIFIED. THE LOCKING OF THE CORELOCK DURING THE INITIAL SURGERY HAS NOT BEEN PERFORMED AS SPECIFIED IN THE SURGICAL TECHNIQUE USING ONLY THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. INSTEAD, ADDITIONALLY A NON-TORQUE LIMITING SCREWDRIVER WAS USED. IT REMAINS UNKNOWN WHAT THE POTENTIAL EFFECT OF THIS DEVIATION FROM THE SURGICAL TECHNIQUE COULD BE. BASED ON THE INVESTIGATION THE REPORTED EVENT CAN BE CONFIRMED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT FURTHER POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION AND BEHAVIOUR, IMPLANTATION PROCEDURE OR DESIGN FEATURES. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE BACKING OUT OF THE SCREW REMAINS UNKNOWN. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED FOR THE TIME BEING AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. D10: MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X44MM; CATALOG#: 47-2486-044-40; LOT#: 3006007. BLUNT TIP SCREW, 4X44MM; CATALOG#: 47-2486-044-40; LOT#: 3010653. PROXIMAL HUMERUS, LEFT, LONG, 10X 240MM; CATALOG#: 47-2496-241-09; LOT#: 3010778. CORTICAL BONE SCREW, 4X24MM; CATALOG#: 47-2486-124-40; LOT#: 3053501. CORTICAL BONE SCREW, 4X26MM; CATALOG#: 47-2486-126-40; LOT#: 3008330. PROXIMAL HUMERUS NAIL CAP, 0MM; CATALOG#: 47-2488-010-00; LOT#: 3046108. TORQUE LIMITING HANDLE; CATALOG#: 27923; LOT# UNKNOWN. LG CANN SCREWDRIVER HANDLE; CATALOG#: 214149000; LOT#: UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON JUL 07, 2021. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT A REVISION SURGERY DUE TO IMPLANT MIGRATION. A MONTH POST THE IMPLANTATION SURGERY, THE SECOND BLUNT SCREW HAD GRADUALLY MIGRATED FROM ITS POSITION, ONLY THIS SCREW HAS BEEN REVISED. THE TORQUE DRIVER WAS USED TO ENGAGE THE CORELOCK, FURTHERMORE NON-TORQUE DRIVER WAS USED TO TIGHTEN MORE AFTER USING THE TORQUE DRIVER.
MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X44MM; CATALOG#: 47-2486-044-40; LOT#: 3006007; BLUNT TIP SCREW, 4X44MM; CATALOG#: 47-2486-044-40; LOT#: 3010653; PROXIMAL HUMERUS, LEFT, LONG, 10X 240MM; CATALOG#: 47-2496-241-09; LOT#: 3010778; CORTICAL BONE SCREW, 4X24MM; CATALOG#: 47-2486-124-40; LOT#: 3053501; CORTICAL BONE SCREW, 4X26MM; CATALOG#: 47-2486-126-40; LOT#: 3008330; PROXIMAL HUMERUS NAIL CAP, 0MM; CATALOG#: 47-2488-010-00; LOT#: 3046108. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED X-RAYS FOR REVIEW. OTHER DOCUMENTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT A REVISION SURGERY DUE TO IMPLANT MIGRATION. A MONTH POST THE IMPLANTATION SURGERY, THE SECOND BLUNT SCREW HAD GRADUALLY MIGRATED FROM ITS POSITION, ONLY THIS SCREW HAS BEEN REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1021178 | BLUNT TIP SCREW, 4X44MM | AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL | HSB | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 3054470 | 00889024505469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Hospitalization| R |