MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-25 for ZIMMER SKIN GRAFT MESHER 00770100000 manufactured by Zimmer Surgical, Inc..
[186734815]
This event has been recorded by zimmer biomet under (b)(4). Once the investigation is completed, a follow-up/final report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[186734816]
It has been reported that the mesher was working backwards. The handle would not scratch it properly, and the gears possibly were not meshing. Hospital tried using the mesher during a case that required skin grafting, however the handle will not engage properly, and the skin graft carrier will go backwards. The event occurred during surgery. This piece of equipment is not used very often, and it is believed this was the first time we? Ve used it after it came back from its previous repair. No harm, no delay, no additional graft required. The procedure was delayed significantly(approximately 45-min,) due to the fact that hospital had to find a solution to make the mesher work, as the skin graft area was a large one, and we needed the skin meshed( manually putting slits in the skin was not an option because of the large graft needed). No adverse event was reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00310 |
| MDR Report Key | 9876722 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-04 |
| 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 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 | ZIMMER SKIN GRAFT MESHER |
| Generic Name | EXPANDER, SURGICAL, SKIN GRAFT |
| Product Code | FZW |
| Date Received | 2020-03-25 |
| Catalog Number | 00770100000 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-25 |