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

Catalog Number 00882100100

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).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 product review of the electric dermatome on (b)(6) 2019 revealed that the calibration was out of specifications at the zero setting only.The motor speed was out of specifications and the control bar was in the correct position.The customer did not return a power supply for evaluation.Repair of the electric dermatome was performed by zimmer biomet surgical on (b)(6) 2019 which included replacement of the seal/strain relief, o-ring, end cap, plug harness assembly, switch mount, switch, motor, hand piece insulator, motor seal, etched lever, ball bearings, and spring seal.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The root cause of the reported event cannot be specifically determined with the provided information because the reported event was unable to be reproduced during evaluation.The power supply was not returned for evaluation.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 during testing the device had no power and did not result in any harm.According to the investigation the motor speed was below specifications.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: 9447139
• MDR Text Key: 197320284
• Report Number: 0001526350-2019-01128
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• 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: 61678055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2010
• 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