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 2020-03-31 for ULNAR BEARING ASSEMBLY TOOL N/A 00840108100 manufactured by Zimmer Biomet, Inc..
[187368847]
(b)(4). Concomitant medical products: part 00840009400; articulation kit size 4 1 axle pin, 1 humeral bearing a, 2 ,ulnar bearings b sterile product do not resterilize; lot# unknown, unknown humeral component, unknown ulnar component. Report source: (b)(6). Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[187368848]
It was reported that the assembly tool would not engage with the poly. The triceps was completely removed as it was difficult to put the final assembly together. There was a delay of two hours as a result of this failure. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01189 |
| MDR Report Key | 9906190 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2019-11-18 |
| Date Added to Maude | 2020-03-31 |
| 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 | ULNAR BEARING ASSEMBLY TOOL |
| Generic Name | EXTREMITIES, INSTRUMENT |
| Product Code | JDC |
| Date Received | 2020-03-31 |
| Model Number | N/A |
| Catalog Number | 00840108100 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |