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

Model Number N/A

Device Problem Failure to Cut (2587)

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).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.

Event Description

It was reported that the device was destroying skin.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).Reported issue: on june 13, 2019, it was reported that the device was destroying skin.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.Dhr review: 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.Zimmer biomet surgical has previously repaired/evaluated air dermatome serial number (b)(4) one time as documented in the repair reports in livelink.The last repair was (b)(4).2018 where it was reported that the device was missing screws and the reciprocating arm, bearings, seal and retaining ring, motor, swivel, poppet assembly, and width plate screws were replaced.This is not a related issue.Device evaluations results/investigation findings: product review of the air dermatome on june 24, 2019 revealed that the calibration was out of specifications at the zero setting only.The motor speed was within specifications and the control bar was within specifications.The head and control bar had some visible damage.Repair of the air dermatome was performed by zimmer biomet surgical on june 24, 2019 which included replacement of the machined head, die cast lever, screws, neckpiece, needle bearing, spring pin, semi-circle bearings, vespel bearings, thickness control shaft, external e-ring, reciprocating arm, bearings, retaining ring, spring seal, o-rings, fine adjustment cam, and ball plunger.Air dermatome, serial number 107227, was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: although the reported event was confirmed during inspection of the device, and the device was functioning as intended after the components were replaced, it cannot be determined from the information provided what caused the reported event.Therefore the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information available.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8747862
• MDR Text Key: 149638149
• Report Number: 0001526350-2019-00519
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• 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: 33213900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1