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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).On (b)(6) 2017, it was reported that the device had intermittent power.The motor was corroded and the cord was damaged.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.The customer also returned a sterilization case, screwdriver and 1/2/3/4 width plates, 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.Product review of the electric dermatome by medicrea on (b)(6) 2017 revealed that the motor was corroded and the power cord was damaged.The lever and reciprocating arm were worn.Repair of the electric dermatome was performed by medicrea on (b)(6) 2017 which included replacement of the ball bearing, spring seal, needle bearing, semi-circle bearing, vespel sleeve bearing, motor, lever, ball plunger, reciprocating arm, plug harness and seal/strain relief.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during the product review by medicrea it was noted that the motor was corroded and the power cord was damaged.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 the power cord was damaged.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.

Event Description

It was reported that the device had intermittent power, motor was corroded and the cord also got damaged.The device was sent to medicrea for repair.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8070881
• MDR Text Key: 128594469
• Report Number: 0001526350-2018-01038
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/14/2018

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: 63095204
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1