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

Catalog Number 00882100100

Device Problems Component Missing (2306); Output below Specifications (3004)

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

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: no: (b)(4).Telephone number: (b)(6).On (b)(6) 2019, it was reported that the device did not start up when plugged to mains.The blade and spacer were replaced the unit started up with no problem.Similar situation occurred number of times.Customer requested repair/checkup of the unit.The customer returned an electric dermatome device, serial number ((b)(4)), for evaluation.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.Product review of the electric dermatome by zimmer biomet on 05 november 2019 revealed that the reported event was confirmed as the motor speed was not steady, the unit was out of calibration, the needle bearing was worn, and the control bar was too thing at the edges.It was also noted that the device had non original screws installed at the neck.Repair of the electric dermatome was performed by zimmer biomet which included replacement of the needle bearing, shaft bearings, sleeve bearings, control bar, motor, and screws.Electric dermatome, serial number ((b)(4)), was then tested and functioned properly.It was repaired, inspected and tested.Although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the components to fail.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.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

This device was sent in for annual/preventative maintenance and there was no event.During evaluation of the device, it was revealed that the motor speed was not steady and the device did not have the original screws installed at the neck.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: 9607915
• MDR Text Key: 193634525
• Report Number: 0001526350-2020-00079
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• 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: 63733145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1