MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME

Catalog Number 00882100100

Device Problem Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).Reported issue: on (b)(6) 2018, it was reported that during preventative maintenance by zimmer biomet surgical it was noted that the motor was operating erratically within motor speed specifications.The head and control bar had visible damage and all of the width plates that were sent in were damaged.The customer returned an electric dermatome device, serial number (b)(4) for evaluation.The customer also returned an autoclave case, screwdriver, 1 inch /2 inch /3 inch /4 inch width plates and power supply, serial number (b)(4) for evaluation.Dhr review: the device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated electric dermatome serial number (b)(4) as documented in the repair reports in livelink.Zimmer biomet surgical has previously repaired/evaluated electric dermatome power supply serial number (b)(4) as documented in the repair reports in livelink.Of the 6 complaints, 1 was the reported event while 3 others appeared to be related to a motor issue based off of their reported events.After review, it was found that only 2 of the 3 complaints had a confirmed motor issue.No additional actions are required at this time.Device evaluations results/investigation findings: product review of the electric dermatome on july 21, 2018 revealed that the calibration was out of specifications at the zero thickness setting but within at all other settings.The device operated within motor speed specifications but it was noted that the motor was operating erratically.The head and control bar had visible damage and all of the width plates that were sent in were damaged.Repair of the electric dermatome was performed by zimmer biomet surgical on july 21, 2018 which included replacement of the power cord assembly, power switch, bearings, seal and retaining ring, motor, o-ring, damaged head, damaged control bar, screwdriver and width plates.Electric dermatome, serial number (b)(4) was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: the root cause of the reported event could not be specifically determined with the information that was provided.During the product review it was noted that the motor was operating erratically within motor speed specifications.The head and control bar had visible damage and all of the width plates that were sent in were damaged.It is unknown with the information that was provided how this occurred.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

It was reported that initially the complaint was found that it was preventive maintenance.Later, it was noticed that the unit required repair.The calibration setting was out of specification at 0 but within at all others.The rpm's were within specifications but the motor ran erratically.The head and control bar had visible damaged.All width plates sent were damaged.The head and control bar were replaced.The cord assembly, motor and switch were replaced.All width plates sent were replaced.The screwdriver was replaced.No adverse events were reported as a result of this malfunction.

• Brand Name: HANDPIECE, ELECTRIC 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: 9030061
• MDR Text Key: 158861674
• Report Number: 0001526350-2019-00779
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 63526264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• 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