MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME, LINE-POWERED

Catalog Number 00882100100

Device Problem Electrical Power Problem (2925)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet (b)(4).The customer has indicated that the device is being returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It was reported that the device had damaged power cord plug.Event occurred during reprocessing and there was no harm, no delay reported.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).This med watch is being filed to relay additional information.The following sections were updated/corrected: b4, d4, d10, g4, g7, h2, h3, h4, and h10.The device history record 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.Zimmer biomet surgical has previously repaired/evaluated electric dermatome serial number(b)(6) three times as documented in the repair reports.The last repair was (b)(6) 2018 where it was reported that the device will not run and the power cord assembly, power switch, ball detent, thickness lever, reciprocating arm, bearings, seal and retaining ring, motor, o-ring, machined head, control bar, and calibration shaft were replaced.This is not a related issue.On (b)(6) 2019, it was reported that the device had damaged power cord plug.The customer returned an electric dermatome device, serial number(b)(6), for evaluation.Product review of the electric dermatome on (b)(6) 2019 revealed that the power cord was broken at the plug end so the motor speed could not be tested.The calibration was out of specifications at the zero setting only.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, plug harness assembly, motor, switch, semi-circle bearings, vespel bearings, needle bearing, ball bearings, and spring seal.Electric dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.The device was noted to be functioning as intended after the seal/strain relief, o-ring, plug harness assembly, motor, switch, semi-circle bearings, vespel bearings, needle bearing, ball bearings, and spring seal.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.While the returned product investigation confirmed that the electric dermatome had a damaged power cord plug, 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.

Event Description

No additional information was received.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME, LINE-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8608883
• MDR Text Key: 145009003
• Report Number: 0001526350-2019-00370
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• 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: 63123287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1