MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE; DERMATOME, PNEUMATICALLY-POWERED

Model Number N/A

Device Problems Failure to Cut (2587); Physical Resistance/Sticking (4012)

Patient Problem Abrasion (1689)

Event Date 05/18/2022

Event Type  Injury  

Event Description

It was reported that the device gets stuck (chops) and goes unevenly.The event timing was during surgery.There was a 30 minute delay and an additional graft was needed.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

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

Event Description

No additional event information available.

Manufacturer Narrative

Review of the most recent repair record determined the repair site was unable to duplicate the reported issue.The calibration was out at the zero reading, the machined head and screw were damaged, and the reciprocating arm were worn.The machined head, screws, reciprocating arm, and bearings were replaced and resolved the reported issue.It was noted that this unit was manufactured in november of 2017 and has not been returned for preventative maintenance.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 event information available.

• Brand Name: DERMATOME AN HANDPIECE
• Type of Device: DERMATOME, PNEUMATICALLY-POWERED
• 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: 14675066
• MDR Text Key: 293843129
• Report Number: 0001526350-2022-00560
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024464834
• UDI-Public: (01)00889024464834(11)171103(10)63817639
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 88710100
• Device Lot Number: 63817639
• 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: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other