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

Model Number N/A

Device Problems Loss of Power (1475); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The device starts and stops when trying to use.The event occurred before surgery.The event did not occur before its first use.No adverse events were reported as a part of this malfunction.

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: date of report, serial#, concomitant medical products, date rec¿d by mfr, pma/510k, if follow-up, what type, device evaluated by mfr, device manufacture date.On (b)(6) 2018, it was reported that the device starts and stops when trying to use.The customer returned an electric dermatome device, serial number: (b)(4), for evaluation.The customer also returned a power supply, serial number: (b)(4), for evaluation.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.Medicrea has not previously repaired/evaluated electric dermatome serial number: (b)(4) as documented in the vdoc service portal.Medicrea has not previously repaired/evaluated electric dermatome power supply serial number: (b)(4) as documented in the vdoc service portal.Product review of the electric dermatome by medicrea on august 8, 2018 revealed that the motor was corroded and had no torque.The thickness control shaft was not complying with the input tests and the power cable was pulled out of the dermatome.The electric dermatome power supply, serial number: (b)(4), functioned as intended.Repair of the electric dermatome has not yet been performed by medicrea.The reported event was confirmed since during the product review by medicrea it was noted that the motor was corroded and had no torque.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review by medicrea it was noted that the motor was corroded and had no torque.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.

• 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: 7758017
• MDR Text Key: 116874291
• Report Number: 0001526350-2018-00758
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 62525826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1