BLUNT TIP SCREW, 4X38MM
Report
- Report Number
- 0009613350-2023-00195
- Event Type
- Injury
- Date Received
- April 26, 2023
- Date of Event
- April 5, 2023
- Report Date
- May 23, 2023
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- HSB
- UDI-DI
- 00889024505438
- 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
- Health Professional
- Yes
Narratives
(B)(6). G-2: FOREIGN: JAPAN D-10: PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM; ITEM# 47249624008, LOT# 3059713 BLUNT TIP SCREW, 4X40MM; ITEM# 47248604040, LOT# 3091510 BLUNT TIP SCREW, 4X42MM; ITEM# 47248604240, LOT# 3082110 ANN BLUNT TIP SCREW 4X44MM; ITEM# 47248604440, LOT# 3091413 ANN CORT BONE SCREW 4X24MM; ITEM# 47248612440, LOT# 3136323 ANN BLUNT TIP SCREW 4X42MM; ITEM# 47248604240, LOT# 3082111 ANN CORT BONE SCREW 4X24MM; ITEM# 47248612440, LOT# 3054478 AFFIXUS PH NL CAP 10.5X2.5MM; ITEM# 47248801002, LOT# 3091585 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2023 - 00193 0009613350 - 2023 - 00196 0009613350 - 2023 - 00197 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. IT CAN BE ASSUMED THAT MULTIPLE FACTORS, RELATED TO EITHER PATIENT CONDITION, BEHAVIOR OR IMPLANTATION PROCEDURE, CONTRIBUTED TO THE MIGRATION OF THE SCREWS. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE LOCKING MECHANISM OF THE NAIL AS A POTENTIAL CONTRIBUTING FACTOR. AS PART OF THE DEEPER INVESTIGATION, A SCIENTIFIC LITERATURE SEARCH WAS CONDUCTED AND A SYSTEMATIC REVIEW OF THE OUTCOME OF INTRAMEDULLARY NAILING FOR ACUTE PROXIMAL HUMERUS FRACTURE SHOWED THAT SCREW MIGRATION AND PERFORATION INTO THE JOINT IS THE SECOND MOST COMMON COMPLICATION FOLLOWING SECONDARY LOSS OF REDUCTION. IN ADDITION, SCIENTIFIC LITERATURE OF COMPETITOR AND PREDICATE DEVICES WERE ASSESSED. THIS REVIEW HAS SHOWN THAT THE NAIL PROXIMAL HUMERAL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT ONE MONTH AFTER INITIAL RIGHT HUMERAL NAIL IMPLANTATION ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM ITS PROPER POSITION. NO INTERVENTION IS PLANNED AT THIS TIME. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 791441 | BLUNT TIP SCREW, 4X38MM | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 3132512 | 00889024505438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose | Other |