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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).Current repair, product evaluation, product review of the air dermatome serial number (b)(4) by (b)(6) on (b)(6) 2020 revealed that the motor was not running so the rpms could not be checked.The head and control bar were also nicked which could affect the performance of the device.The neck and hand piece also had considerable wear and rust.The device was manufactured before august 12 1992.Product repair: repair of the device was performed by (b)(6) on (b)(6) 2020 which included replacement of the following: an aged repair which included the month and year the device was repaired being etched into the new handpiece, the device was completely rebuilt with new components.Components replaced include bearings, gears, hinges, throttle, poppet, washer, o-rings, poppet housing, spring pin, spring, rings, cams, lever, thickness control shaft, screws, reciprocating arm, swivel, plunger, carrier, motor, motor sleeve, head, neckpiece, and other parts.The device, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.

Event Description

It was reported that the device had motor issues during surgery and resulted in no harm and no delay.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: 10367608
• MDR Text Key: 201699622
• Report Number: 0001526350-2020-00655
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2020
• 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