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

Catalog Number 00880100100

Device Problem Output below Specifications (3004)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) review was unable to be performed as the dhr associated with this device is not available.This device was manufactured prior to may 2009 where it was identified a robust dhr indexing and handling process was not in place.A corrective and preventative action (capa) (b)(4) implemented a serial number logbook to correct this issue.The 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 previous repair report review also found that all verifications, inspections and tests were successfully completed.On january 31, 2020, it was reported that the unit was found in need of repair during test and calibration.The customer returned an air dermatome device, serial number (b)(4), for evaluation.The customer also returned a hose and 1"/2"/3"/4" width plates, for evaluation.Product review of the air dermatome on january 30, 2020 revealed that the motor speed was below specifications.The control bar was in the correct position and the calibration was out of specifications at the zero setting only.Repair of the air dermatome has not been performed by zimmer biomet surgical as the device is aged and the customer was unresponsive so the device will be returned to them unrepaired.While the returned product investigation confirmed that the air dermatome had a malfunctioning motor, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The device was not repaired as the customer was unresponsive to the repair quote.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 this device was found to be in need of repair during test and calibration.During investigation, it was discovered that the device was operating below motor speed specifications.No adverse events were reported as a result of this malfunction.

• 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: 9792766
• MDR Text Key: 197924234
• Report Number: 0001526350-2020-00254
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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