MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for SCREWDRIVER HEX BALL END 3.5MM N/A 32-467201 manufactured by Zimmer Biomet, Inc..
[185972025]
(b)(4). Concomitant medical products: vngd ssk 360 femur r 67. 5 t 67. 5mm item# 185265 lot# 6058568. Report source: (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185972026]
It was reported that when tightening the femoral screw into the femur implant the hex ball end of the screwdriver snapped off and got stuck in the head of the screw. Several attempts were made to remove it but it was flush with the head of the screw and looks as though it may have cold welded on. The surgeon decided to implant the femur as he is confident that the fragment will not come out. He covered the screw head with cement to ensure it does not come out. There is no additional information available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01273 |
| MDR Report Key | 9878920 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-18 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCREWDRIVER HEX BALL END 3.5MM |
| Generic Name | SCREWDRIVER |
| Product Code | HXX |
| Date Received | 2020-03-25 |
| Model Number | N/A |
| Catalog Number | 32-467201 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-25 |