MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-17 for ZIMMER SKIN GRAFT MESHER 00770100000 manufactured by Zimmer Surgical, Inc..
[187246913]
This event has been recorded under zimmer biomet complaint number (b)(4). Concomitant medical products: associated devices: 00770301500, z. S. G. M. Cutter 1. 5:1 ratio caution: sharp, 60048059, (b)(4). 00770302000, z. S. G. M. Cutter 2:1 ratio caution: sharp, 60111373, (b)(4). 00770303000, z. S. G. M. Cutter 3:1 ratio caution: sharp, 60111374, (b)(4). 00770304000, z. S. G. M. Cutter 4:1 ratio caution: sharp, 60105332, (b)(4). On (b)(6) 2020, it was reported that the device required repair during testing. The customer returned a skin graft mesher device, serial number (b)(4), for evaluation. The customer also returned a 1. 5:1 ratio cutter, serial number (b)(4), a 2:1 ratio cutter, serial number (b)(4), a 3:1 ratio cutter, serial number (b)(4), and a 4:1 ratio cutter, serial number (b)(4), for evaluation. Product review of the skin graft mesher on (b)(6) 2020 revealed that the calibration was within specification and the device produced a passing sample mesh. The 1. 5:1 ratio cutter, serial number (b)(4), 2:1 ratio cutter, serial number (b)(4), 3:1 ratio cutter, serial number (b)(4), and 4:1 ratio cutter, serial number (b)(4). All produced an incomplete mesh and were deemed non-repairable. Repair of the skin graft mesher was performed by zimmer biomet surgical on (b)(6) 2020 which included replacement of the carrier guide, screws, comb, and comb shaft. Skin graft mesher, serial number (b)(4), was then tested and functioned properly. It was repaired, inspected and tested. Based on the information provided, the root cause of the reported event was due to the use of damaged cutters. The zimmer skin graft mesher instruction manual notes on page 1 that "a damaged cutter may result in a less than optimal mesh pattern and cause further damage to the mesher".
Patient Sequence No: 1, Text Type: N, H10
[187246914]
It was reported that the device required repair during testing. There was no harm. During investigation, it was identified that the device did not produce a passing test mesh. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00284 |
| MDR Report Key | 9841642 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2003-07-30 |
| Date Added to Maude | 2020-03-17 |
| 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, SKIN GRAFT, SURGICAL |
| Product Code | FZW |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-02-07 |
| Catalog Number | 00770100000 |
| Lot Number | 60075689 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-17 |