MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for 2.0 MM/ 2.4 MM SYSTEM 45 MM, LONG, DEPTH GAGE N/A 01-9125 manufactured by Biomet Microfixation.
[132796359]
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00021 through 0001032347-2019-00024.
Patient Sequence No: 1, Text Type: N, H10
[132796360]
It was reported the depth gage was broken. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00021 |
| MDR Report Key | 8233115 |
| Date Received | 2019-01-10 |
| Date of Report | 2019-02-20 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2015-06-30 |
| Date Added to Maude | 2019-01-10 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 2.0 MM/ 2.4 MM SYSTEM 45 MM, LONG, DEPTH GAGE |
| Generic Name | DEPTH GAGE |
| Product Code | EIL |
| Date Received | 2019-01-10 |
| Returned To Mfg | 2018-12-27 |
| Model Number | N/A |
| Catalog Number | 01-9125 |
| Lot Number | 612980 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-10 |