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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).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

It was reported that during surgery the device was not functional and lost power.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

The customer returned an electric dermatome device for evaluation.The device history record (dhr) reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated this electric dermatome.Initial qa inspection of the electric dermatome by zimmer biomet surgical revealed that the unit was corroded and had dried blood packed crevices.The head and control bar were chipped.It was also revealed that the motor was seized up and heavily corroded and the device was out of calibration at zero setting only.Repair of the electric dermatome was performed by zimmer biomet surgical which included replacement of the ball detent, head, control bar, thickness lever, reciprocating arm, poppet assembly, motor, ¿o¿-ring, swivel, seal and retaining ring.The electric dermatome was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during initial inspection it was revealed that the was heavily corroded and seized up.The root cause of the reported event was due to the corroded motor.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the repairs were performed.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.The electric dermatome was repaired, tested and returned to the customer.

• Brand Name: 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: 6726134
• MDR Text Key: 80496302
• Report Number: 0001526350-2017-00427
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: MO
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

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: 63430535
• Other Device ID Number: (01)00889024375994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 02/14/2018
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2016
• 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