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

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.(b)(6).

Event Description

It was reported that the device did not cut the correct depth.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Upon receipt of additional information, it was found that the event occurred during surgery.The blade did not cut deep enough and the graft that was harvested was not the thickness they wanted.They were able to use the graft anyhow.There was no harm to the patient or delay in procedure.

Event Description

It was reported that the device did not cut the correct depth.Upon receipt of additional information, it was found that the event occurred during surgery.The blade did not cut deep enough and the graft that was harvested was not the thickness they wanted.They were able to use the graft anyhow.There was no harm to the patient or delay in procedure.No adverse events were reported as a result of this malfunction.

Event Description

There is no additional information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the device was out of calibration.The shaft and sleeve bearings were replaced to aid on calibration and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

• 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: 12274457
• MDR Text Key: 264970570
• Report Number: 0001526350-2021-00875
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: 63578131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1