MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

Model Number N/A

Device Problems Unstable (1667); Naturally Worn (2988)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

It was reported that during maintenance on 08 nov 2023, device was found to have worn screws and low motor speed.There was no patient involvement, impact, or harm reported.Due diligence is in process.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).E1 telephone number: (b)(6).G2 foreign: belgium.Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, d4, e1, g1, g3, g6, h1, h2, h3, h4, h6, and h10.Review of the most recent repair record determined the motor speeds were low and the width plate screws were worn.The motor, sleeve, and screws were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.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.E1 telephone number: (b)(6).

Event Description

There is no additional information available regarding the event.

• Brand Name: ZIMMER AIR 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: 18260556
• MDR Text Key: 329638780
• Report Number: 0001526350-2023-01599
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: 00880100100
• Device Lot Number: 61707970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2011
• 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 Sex: Prefer Not To Disclose