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

Model Number N/A

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

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that prior to surgery the device produced an irregular cut and had a stuck motor.No harm or delay were reported as it relates to this event.No adverse events were reported as it relates to this event.

Manufacturer Narrative

This incident has been submitted 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 incident has been recorded under (b)(6).Updates performed on b4 b5 d4 d9 g3 g6 h2 h3 h4 h6 h10 review of the most recent repair record determined that the unit had cable contact issues and found possible corrosion on the motor.The motor and plug harness assembly were replaced and resolved the reported issue.A definitive root cause cannot be determined.The event is 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

No additional information is available.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• 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: 14874099
• MDR Text Key: 302580178
• Report Number: 0001526350-2022-00633
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375994
• UDI-Public: (01)00889024375994(11)180302(10)63962143
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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: 00882100100
• Device Lot Number: 63962143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2018
• 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