MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE

Model Number N/A

Device Problems Incorrect Measurement (1383); Failure to Cut (2587); Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that the grafts are currently being harvested at 15-16/1000" which is not the normal depth we harvest our skin grafts.The current grafts are extremely thin, even at the 16/1000th depth (normal graft harvest is 12/1000" in a teenager/adult patient.Timing - n/a, no harm, no delay.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4) this medwatch is being filed to relay additional information.The following sections have been updated: b4, d4, d8, g3, g6, h2, h3, h6, h10.Review of the most recent repair record determined the rpms and calibration were in specification.The control bar was repositioned and the device was recalibrated which resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.

Event Description

No additional event information.

• Brand Name: DERMATOME AN HANDPIECE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11285386
• MDR Text Key: 230506064
• Report Number: 0001526350-2021-00135
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 88710100
• Device Lot Number: 64479606
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1