MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for DRILL STANDARD 2.0 MM DIAMETER 00236017520 manufactured by Zimmer Biomet, Inc..
[185713275]
(b)(4). Report source: foreign-(b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. 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
[185713276]
It was reported that the drill bit was found broken before the surgery. There was no patient involvement or harm to the patient as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00938 |
| MDR Report Key | 9902710 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-01-08 |
| 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 | DRILL STANDARD 2.0 MM DIAMETER |
| Generic Name | BIT, DRILL |
| Product Code | HTW |
| Date Received | 2020-03-31 |
| Catalog Number | 00236017520 |
| Lot Number | 63914587 |
| 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 | 2020-03-31 |