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 2020-03-31 for HANDPIECE, ELECTRIC DERMATOME 00882100100 manufactured by Zimmer Surgical, Inc..
[186576437]
This event has been recorded by zimmer biomet under (b)(4). Investigation completed. This report is being submitted as an initial final submission. On january 17, 2020, it was reported to be in need of repair for unknown reason. The customer returned an electric dermatome device, serial number (b)(4), for evaluation. The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device. The dhr review also found that all verifications, inspections and tests were successfully completed. Product review of the electric dermatome by zimmer biomet (b)(4) on february 25, 2020 revealed the screws were missing and the needle bearing failure could be confirmed. Repair of the electric dermatome was performed by zimmer biomet (b)(4) on february 13, 2020 which included replacement of the needle bearing. Electric dermatome, serial number (b)(4), was then tested and functioned properly. The root cause of the reported event could not be specifically determined with the information that was provided. During the product review by zimmer biomet (b)(4), it was noted that the screws were missing and the needle bearing failed. It is unknown with the information that was provided how this occurred. 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
[186576438]
It was reported to be in need of repair for unknown reason. Event occurred during kit inspection. At evaluation / investigation the device was found to be missing screws. No adverse events were reported as a result of this malfunction. No additional event information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00330 |
| MDR Report Key | 9904394 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2001-10-01 |
| Date Added to Maude | 2020-03-31 |
| 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 | HANDPIECE, ELECTRIC DERMATOME |
| Generic Name | DERMATOME |
| Product Code | GFD |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-01-24 |
| Catalog Number | 00882100100 |
| Lot Number | 33018800 |
| 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 | 2020-03-31 |