MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-19 for ZIMMER SKIN GRAFT MESHER N/A 00770100000 manufactured by Zimmer Surgical, Inc..
[186699705]
This event has been recorded by zimmer biomet under (b)(4). The device history record and previous repair 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 reviews 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 was not working. The customer returned a zimmer skin graft mesher serial number (b)(4) for evaluation. (during) evaluation of the device on 11 december 2019, it was noted that the comb was damaged. No testing could be performed with the mesher due to the damaged comb. Repair of the mesher occurred the same day and involved replacing the comb. 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 confirmed that the comb was damaged, which would prevent the device from operating as intended, it cannot be determined from the information provided as to what caused the comb to become damaged. Therefore, the root cause of the reported event cannot be determined. 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
[186699706]
It was reported that the unit came from the theatre marked as not working. There was no harm to the patient and no impact to graft. Event occurred in (b)(6) 2019. No adverse event was reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00296 |
| MDR Report Key | 9856836 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2013-05-08 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| Returned To Mfg | 2019-12-13 |
| Model Number | N/A |
| Catalog Number | 00770100000 |
| Lot Number | 62367113 |
| 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 | 2020-03-19 |