PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM
Report
- Report Number
- 0009613350-2022-00077
- Event Type
- Injury
- Date Received
- February 15, 2022
- Date of Event
- January 14, 2022
- Report Date
- February 24, 2022
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- HSB
- UDI-DI
- 00889024505964
- PMA / PMN Number
- K181827
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THERAPY DATE: (B)(6) 2022. MEDICAL PRODUCT: BLUNT TIP SCREW, 4X44MM; CATALOG#: 47-2486-044-40; LOT#: 3054485 . CORTICAL BONE SCREW, 4X26MM; CATALOG#: 47-2486-126-40; LOT#: 3073720. PROXIMAL HUMERUS NAIL CAP, 0MM; CATALOG#: 47-2488-010-00; LOT#: 3073674. BLUNT TIP SCREW, 4X44MM; CATALOG#: 47-2486-044-40; LOT#: 3010657. TORQUE LIMITING HANDLE; CATALOG#: 27923; LOT#: UNKNOWN. X-RAYS, PHOTOGRAPHS, WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00076.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. EVENT DESCRIPTION: IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL ON (B)(6), 2021. AFTER 3 WEEKS FROM THE INITIAL, PATIENT STARTED REHABILITAION AGGRESSIVELY. AFTER 4 WEEKS, SURGEON FOUND #1 SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THEREFORE, REVISION SURGERY WAS PERFORMED ON (B)(6), 2022, AND THE MIGRATED SCREW WAS EXPLANTED. PATIENT INVOLVEMENT - REVISION. NO DELAY. THE CORELOCK MECHANISM WAS UTILIZED. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. X-RAYS: ONE X-RAY WAS AVAILABLE. THE X-RAY CONFIRMS THE MIGRATION OF THE MOST PROXIMAL SCREW. IMAGES: SEVERAL PICTURES WERE RECEIVED. THE PICTURES SHOW THE EXPLANTED SCREW. THERE ARE SOME DAMAGES ON THREAD VISIBLE. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE 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. SURGICAL TECHNIQUE SAP: THE SURGICAL TECHNIQUE 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 OPERATION WAS PERFORMED WITH ANN NAIL ON (B)(6), 2021. AFTER 3 WEEKS FROM THE INITIAL, PATIENT STARTED REHABILITAION AGGRESSIVELY. AFTER 4 WEEKS, SURGEON FOUND #1 SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THEREFORE, REVISION SURGERY WAS PERFORMED ON (B)(6), 2022, AND THE MIGRATED SCREW WAS EXPLANTED. PATIENT INVOLVEMENT - REVISION. NO DELAY. THE CORELOCK MECHANISM WAS UTILIZED. 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). THE RECEIVED X-RAY AND IMAGES CONFIRM THE REPORTED EVENT, NAMELY THAT THE MOST PROXIMAL SCREW HAS MIGRATED. NO PRODUCT WAS RETURNED; THEREFORE, DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR, 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. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW.FURTHER INVESTIGATION HAS BEEN INITIATED IN ORDER TO DETERMINE THE NEED OF POTENTIAL CORRECTIVE AND / OR PREVENTIVE ACTIONS. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL. AFTER 3 WEEKS FROM THE INITIAL, PATIENT STARTED REHABILITATION AGGRESSIVELY. AFTER 4 WEEKS, SURGEON FOUND #1 SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THEREFORE, REVISION SURGERY WAS PERFORMED AND THE MIGRATED SCREW WAS EXPLANTED. OUTCOME - REVISION DUE TO MIGRATION.
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1734799 | PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM | AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL | HSB | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 3059713 | 00889024505964 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization| R | SEE H10 NARRATIVE |