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

Catalog Number 00882100100

Device Problem Failure to Cut (2587)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Concomitant medical products - concomitant therapy: item number: 00882100600, item number: power supply, elec.Dermatome, serial number: (b)(4).Report source- foreign - (b)(6).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 unit had abnormal movement.Device was tested before surgery.The event did not occur during surgery, and there was no patient involvement.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

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, d4, g4, g7, h2, h3, h4, h6, h10.Product evaluation: product review of the electric dermatome (b)(6) by dover on (b)(6) 2020 revealed that the motor was running erratically, the head was damaged, and the calibration was out at the 0 setting only.Product repair: repair of the device was performed by dover on (b)(6) 2020 which included replacement of the following: motor, head, bearings additional repair included recalibration the device, serial number (b)(6), was then tested and functioned properly.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.

• 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: 9531332
• MDR Text Key: 197770274
• Report Number: 0001526350-2019-01204
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 61632117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1