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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(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.On (b)(6) 2020, it was reported that this unit was sent in for pm and upon inspection found in need of unknown repair.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 (b)(6), 2020 revealed that the motor speed was within specifications but was erratic.The control bar was not in the correct position and the calibration was out of specifications at the zero setting only.The head and reciprocating arm had visible wear.The control bar had gouges and the swivel doesn't rotate smoothly.While the returned product investigation confirmed that the air dermatome required repair, it cannot be determined from the information provided which component or combination of components caused the pm to escalate to a repair.A number of findings were noted during evaluation could have contributed to the reported event such as the calibration being out of specification at the zero setting, the control bar being in the wrong position, the swivel not rotating smoothly, the head, reciprocating arm, and control bar having visual damage, and the motor running erratically.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 did not respond 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 the device was sent in for a pm, but needed repair upon investigation.Investigation found that the motor while in specifications ran erratically and the device was out of calibration.No adverse event was 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: 9794772
• MDR Text Key: 197150319
• Report Number: 0001526350-2020-00255
• 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: user facility
• 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 Model Number: N/A
• Device Catalogue Number: 00880100100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• 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