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

Catalog Number 00880100100

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.On (b)(6) 2019, it was reported that the device needed for repair/service.The customer returned an air dermatome device, serial number (b)(4), for evaluation.The customer also returned a hose and 1 inch /2 inch /3 inch /4 inch width plates, for evaluation.Product review of the air dermatome by zimmer biomet (b)(6) on (b)(6) 2019 revealed that the 2 inch and 3 inch width plates had nick marks on them.The hose that was returned with the device was non-zimmer biomet.Product review of the air dermatome by zimmer biomet (b)(6) on (b)(6) 2019 revealed that the calibration was out of specifications at all settings.The motor speed was below specifications and the control bar was in the correct position.Repair of the air dermatome was performed by zimmer biomet (b)(6) on (b)(6) 2019 which included replacement of the motor, bearings, o-ring, seal, reciprocating arm, external e-ring, hose, 2 inch, and 3 inch width plates.Air dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The root cause of the reported event cannot be specifically determined with the provided information because it is unknown which exact failure found was causing the unit to not operate properly for the customer.It was found during evaluation that the device was out of calibration at all settings, the motor speed was below specification, the hose was non-zimmer biomet, and the 2 and 3 inch width plates were damaged.All of these failures found could have contributed to the customer reporting that the unit was not operating properly but it is unknown what exact failure the customer was experiencing.The device was noted to be functioning as intended after the motor, bearings, o-ring, seal, reciprocating arm, external e-ring, hose, 2 inch, and 3 inch width plates were replaced and the unit was re-calibrated.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that the device needed for repair/service.Found 2 and 3 inch width plates have nicks.Found hose to be non original.Identified during inspection.No patient involvement.Inspection revealed the motor speed was below specifications.

• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9283706
• MDR Text Key: 178337932
• Report Number: 0001526350-2019-00975
• 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,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 30647700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/1995
• 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