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 2020-03-09 for DERMATOME BLADES NI 00880000010 manufactured by Zimmer Surgical, Inc..
[182607163]
This event has been recorded by zimmer biomet under (b)(4). Once the investigation is completed, a follow-up/final report will be submitted. Unable to return-unavailable by hospital.
Patient Sequence No: 1, Text Type: N, H10
[182607164]
It was reported the hole in the dermatome blade is deviated from the hole in the handpiece, so the blade cannot be inserted into the handpiece. Event did not occur during surgery and there was no patient involvement. No adverse event was reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00266 |
| MDR Report Key | 9806530 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-12-24 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-03-06 |
| Date Added to Maude | 2020-03-09 |
| 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 | DERMATOME BLADES |
| Generic Name | DERMATOME |
| Product Code | GFD |
| Date Received | 2020-03-09 |
| Model Number | NI |
| Catalog Number | 00880000010 |
| Lot Number | 63928823 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-09 |