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 2020-03-09 for ZIMMER SKIN GRAFT MESHER 00770100000 manufactured by Zimmer Surgical, Inc..
[182606627]
This event has been recorded by zimmer biomet under (b)(4). This report is an initial final submission. Investigation completed. The device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device. The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed. On february 19, 2020, it was reported that the mesher had bent tines. 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), for evaluation. Product review of the skin graft mesher on (b)(6) 2020 revealed that the comb was bent. The calibration and sample mesh could not be taken due to the damaged comb. The 1. 5:1 ratio cutter, serial number (b)(4) produced an incomplete mesh and was deemed non-repairable even after changing the collars and gear. Repair of the skin graft mesher was performed by zimmer biomet surgical on (b)(6) 2020 which included replacement of the screws and comb. Skin graft mesher, serial number (b)(4), was then tested and functioned properly. While the returned product investigation confirmed that the skin graft mesher had a bent comb, it cannot be determined from the information provided what actually caused the reported event. Therefore, based on the information provided, a specific root cause of the reported event cannot be determined. The device was noted to be functioning as intended after the screws and comb were replaced. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
Patient Sequence No: 1, Text Type: N, H10
[182606628]
It was reported that after surgery the mesher was found to have bent tines. Evaluation investigation of the device confirmed bent comb. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00262 |
| MDR Report Key | 9806468 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-09 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2009-06-26 |
| 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 | ZIMMER SKIN GRAFT MESHER |
| Generic Name | EXPANDER, SURGICAL, SKIN GRAFT |
| Product Code | FZW |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-02-21 |
| Catalog Number | 00770100000 |
| Lot Number | 61294918 |
| 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 | 2020-03-09 |