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

Catalog Number 00882100100

Device Problems Loss of Power (1475); Electrical Power Problem (2925)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the electric dermatome handpiece seizes and would not function properly.The event occurred during surgery, and there was no harm reported.No adverse events were reported as a result of this malfunction.

Event Description

Event occurred before surgery.There was no patient involvement.No adverse events were reported as a result of this malfunction.No additional event information was received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under(b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d10, g4, g7, h2 h3, h6, h10.Reported issue: on (b)(6)2019, it was reported that the hand piece seizes and would not function properly.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.Dhr review: the device history record (dhr) review was unable to be performed as the dhr associated with this device is not available.This device was manufactured prior to (b)(6) 2009 where it was identified a robust dhr indexing and handling process was not in place.A corrective and preventative action implemented a serial number logbook to correct this issue.The 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 previous repair report review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated electric dermatome serial number (b)(4) seven times as documented in the repair reports in livelink.The last repair was (b)(6)2015 where it was reported that the device needed standard repair and the power cord assembly, power switch, ball detent, thickness lever, reciprocating arm, bearings, seal and retaining ring, motor, o-ring, control bar, and calibration shaft were replaced.This is not a related issue.Device evaluations results/investigation findings: 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 within specifications but ran erratically.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 plug harness assembly, seal/strain relief, o-ring, machined head, motor, switch, needle bearing, die cast lever, throttle lever, reciprocating arm, ball plunger, thickness control shaft, bearings, internal retaining ring, spring seal, spring pin, vespel bearings, and semi-circle bearings.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: the cause of the reported event was due to the motor that was found to be operating erratically.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.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8796028
• MDR Text Key: 151222682
• Report Number: 0001526350-2019-00556
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1