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

Catalog Number 00880100100

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number cmp- 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 november 6, 2019 revealed that motor speed was below specifications.The calibration was within specifications and the control bar was in the correct position.Repair of the air dermatome was performed by zimmer biomet surgical on november 6, 2019 which included replacement of the hose, poppet spring, o-rings, wave washers, o-ring, motor sleeve, motor, needle bearing, throttle lever, reciprocating arm, spring seal, semi-circle bearings, and vespel bearings.Air dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.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 noted to be functioning as intended after the hose, poppet spring, o-rings, wave washers, o-ring, motor sleeve, motor, needle bearing, throttle lever, reciprocating arm, spring seal, semi-circle bearings, and vespel bearings were replaced.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 required pm with no alleged deficiency.The investigation identified that the motor speed was below 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: 9418959
• MDR Text Key: 197752813
• Report Number: 0001526350-2019-01120
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 62682956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2014
• 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