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 2020-03-24 for ZIMMER SKIN GRAFT MESHER N/A 00770100000 manufactured by Zimmer Surgical, Inc..
[186718645]
This event has been recorded by zimmer biomet under (b)(4). Udi: (b)(4). The device history record for zimmer skin graft mesher serial number (b)(4) were reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with the device. The record review found no issues with the device and all verifications, inspections, and tests were successfully completed. On 13 december 2019, it was reported that a mesher had a damaged base and that the mechanism was difficult to open. The customer returned a zimmer skin graft mesher serial number (b)(4) as well as 1. 5:1 cutter serial number (b)(4) for evaluation. Evaluation of the device on 11 december 2019 noted that the comb was damaged at the handle end and that there was a missing ratchet screw on the ratchet. Upon further evaluation, it was found that the handle was disassembled and not lubricated properly. None of the pretests could be performed due to the damaged comb. Review of the returned cutter noted that it produced a passing test mesh. Repair of the mesher occurred the same day and involved replacing the comb and the missing ratchet screw as well as relubricating and reassembling the ratchet. The technician then recalibrated the device and verified that it was functioning as intended. The mesher was then returned to the customer without further incident. The device was tested, inspected, and repaired. While the service technician found that the comb was damaged and there was a missing ratchet screw, there was no findings referring to the base of the device being damaged nor was there mention of the device being difficult to open. As such, a specific cause the reported events cannot be determined. During evaluation of the device though, it was found that the ratchet handle had been improperly lubricated and disassembled. The instructions for use for the zimmer skin graft mesher (zimmer skin graft mesher instruction manual) provides instructions on how to properly assemble and disassemble the device as well as how to lubricate the ratchet on page 7. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Review of the information provided during the investigation determined that there are no further actions needed at this time. This complaint will be tracked and trended for any adverse trends that may warrant further action.
Patient Sequence No: 1, Text Type: N, H10
[186718646]
It was reported that the dermatome was in need of an unknown repair, upon investigation it was found that the dermatome had a damaged comb. There was no adverse event reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00309 |
| MDR Report Key | 9873801 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2018-03-08 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Returned To Mfg | 2020-01-10 |
| Model Number | N/A |
| Catalog Number | 00770100000 |
| Lot Number | 63962170 |
| 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 | 2020-03-24 |