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

Model Number N/A

Device Problems Mechanical Problem (1384); Failure to Disconnect (2541)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).Report source: australia.Review of the most recent repair record identified the following related repair: tech found that the unit was out of calibration, the motor speed was low, the fine adjustment cam had been installed incorrectly, and there was unwanted oil on/in the device.Tech replaced the motor, swivel, motor sleeve, needle bearing, ball bearing, ring gear, and planet gears and cleaned the excess oil from the device.The unit was calibrated, tested, and returned to the customer.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.

Event Description

It was reported the dermatome locked up during surgery and did not engage properly.There was no reported patient harm or delay.At evaluation, it was noted that the device had motor speed issues.Due diligence is complete, and no further information is available at this time.

• 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: 17425473
• MDR Text Key: 320053503
• Report Number: 0001526350-2023-00819
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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: 62682771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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
• Treatment: "4\ "WIDTH PLATE (ZI-00-8802-004-00)",; 1\ "WIDTH PLATE (ZI-00-8802-001-00)"; 2\ "WIDTH PLATE (ZI-00-8802-002-00)",; 3\ "WIDTH PLATE (ZI-00-8802-003-00); AIR HOSE (ZI-00-8801-002-00); SCREW DRIVER (ZI-00-8803-000-00)
• Patient Sex: Prefer Not To Disclose