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

Catalog Number 88710100

Device Problems Failure to Power Up (1476); Power Problem (3010)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.

Event Description

T was reported that the dermatome changed its strength during the withdrawal period.When it returned to the tissue bank, it is cleaned in a dish-disinfector.After this, it did not start at all.The event timing was when the dermatome was taking skin from deceased patients.Therefore, there was no harm or delay reported.No adverse events were reported as a result of this malfunction.Due diligence is in progress for this complaint; to date no additional information has been received.

Manufacturer Narrative

If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

There is no additional event information.

Manufacturer Narrative

Review of the most recent repair record identified no repairs related to the reported event.The reported issues could not be replicated; no problem found.A definitive root cause cannot be determined.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

There is no additional information available.

• Brand Name: DERMATOME AN HANDPIECE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15690683
• MDR Text Key: 302593609
• Report Number: 0001526350-2022-01052
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024464834
• UDI-Public: (01)00889024464834(11)170310(10)63578131
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 88710100
• Device Lot Number: 63578131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1