MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-26 for HANDPIECE, ELECTRIC DERMATOME 00882100100 manufactured by Zimmer Surgical, Inc..
[186734727]
This event has been recorded by zimmer biomet under (b)(4). The investigation is still in progress. Once the investigation is complete a follow up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[186734728]
It has been reported that the device was not making clean cuts, they were jagged. The event timing was during surgery. There was no harm and no delay. No additional graft needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00316 |
| MDR Report Key | 9883964 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-26 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2018-03-02 |
| Date Added to Maude | 2020-03-26 |
| 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 DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANDPIECE, ELECTRIC DERMATOME |
| Generic Name | DERMATOME |
| Product Code | GFD |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-11 |
| Catalog Number | 00882100100 |
| Lot Number | 63962143 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |