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 JGRKNT LONG CURVED DISP KIT N/A 916020 manufactured by Zimmer Biomet, Inc..
[185961214]
(b)(4). Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Discarded
Patient Sequence No: 1, Text Type: N, H10
[185961215]
It was reported during the initial surgery, the drill snapped off in patients bone and buried under the surface. It was left in the patient by the surgeon as it would have been too difficult to retrieve. There is no revision or additional surgery planned to get it out as the surgeon does not believe the patient is compromised. No additional information available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01263 |
| MDR Report Key | 9877562 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-11-03 |
| 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 | JGRKNT LONG CURVED DISP KIT |
| Generic Name | FASTENER, FIXATION |
| Product Code | MBI |
| Date Received | 2020-03-25 |
| Model Number | N/A |
| Catalog Number | 916020 |
| Lot Number | 570420 |
| 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. Other | 2020-03-25 |