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

Catalog Number 00882100100

Device Problem Failure to Cut (2587)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that the device was skipping and not giving a smooth graft.Event occurred during surgery.There was no harm, but there was a delay to obtain a new device.

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: b1, b2, b5, d4, e2, e3, g3, g7,h1, h2, h3,h4, h6 and h10.H6: delay in surgery was at least 30 minutes.The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.On (b)(6)2019, it was reported that the surgeon said it was skipping and not giving a smooth graft.The customer returned an electric dermatome device, serial number (b)(6), for evaluation.Product review of the electric dermatome on (b)(6)2020 revealed that the motor speed was within specification but ran erratically.The calibration was out of specifications at the zero setting only and the control bar was slightly out of position.The customer did not return a power supply for evaluation.While the returned product investigation confirmed that the electric dermatome motor was running erratically, 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 vespel bearings, semi-circle bearings, eccentric shaft, plug harness assembly, motor, switch, seal/strain relief, end cap, and o-ring 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 surgeon said it was skipping and not giving a smooth graft.Event occurred during surgery, there was at least a 30 minute delay in surgery while the patient was under anesthesia.No additional consequences have been 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
• MDR Report Key: 9563525
• MDR Text Key: 190120919
• Report Number: 0001526350-2020-00030
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 64399077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other