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

Model Number N/A

Device Problem Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).(b)(6).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.On (b)(6) 2019, it was reported that the handpiece was plugged into the power supply control unit and the device did not work.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.Product review of the electric dermatome by zimmer biomet (b)(4) on (b)(6) 2019 revealed that the device ran very slow and the oscillator was able to be stopped by hand.The width plates were worn.Product review of the electric dermatome by zimmer biomet (b)(4) on (b)(6) 2019 revealed that the motor speed was below specifications.The calibration was out of specifications at all settings 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 (b)(4) on (b)(6) 2019 which included replacement of the motor, switch, bearings, o-ring, seal, reciprocating arm, external e-ring, and the 1"/2"/3"/4" width plates.Electric 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 electric 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 motor, switch, bearings, o-ring, seal, reciprocating arm, external e-ring, and the 1"/2"/3"/4" width plates 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 handpiece was plugged into the power supply control unit and the device did not work.During evaluation of the device, it was discovered to be running below motor speed 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: 9595526
• MDR Text Key: 195414765
• Report Number: 0001526350-2020-00067
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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: 00882100100
• Device Lot Number: 62786175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• 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