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

Catalog Number 00882100100

Device Problem Electrical Power Problem (2925)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been 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 plug end came off and no power.The event occurred during end of surgery and no harm reported.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).This medwatch is being filed to relay additional information.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.Zimmer biomet surgical has previously repaired/evaluated electric dermatome serial number (b)(4) one time as documented in the repair reports in livelink.The last repair was november 15, 2018 where it was reported that the device was producing very low power and the power cord assembly, power switch, bearings, seal and retaining ring, motor, and o-ring were replaced.This is not a related issue.On april 24, 2019, it was reported that the device plug end came off and no power.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.Product review of the electric dermatome on may 1, 2019 revealed that the plug end of the cord was broken.The motor speed could not be tested due to the broken cord end.The calibration was within 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 may 1, 2019 which included replacement of the seal/strain relief, switch, and plug harness assembly.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Notification number 300168979 dated 4/25/2019.While the returned product investigation confirmed that the electric dermatome had a broken plug at the end of the cord causing the unit to have no power, 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 seal/strain relief, switch, and plug harness assembly were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• 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: 8613229
• MDR Text Key: 145243666
• Report Number: 0001526350-2019-00371
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• 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: 63138521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1