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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).No code available for a prolonged surgical delay.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Received; but not yet evaluated.

Event Description

It was reported that during surgery the device loss power.Thus, causing a surgical delay of 30 minutes to an hour.No additional patient consequences were reported.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).On june 30, 2017, it was reported that the device loss power during use.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.The device history record (dhr) and previous repair report review noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr and previous repair report review found no issues with the device and all verifications, inspections and tests were successfully completed.Medicrea has previously repaired/evaluated electric dermatome serial number (b)(4) one time as documented in the repair reports in livelink.The last repair was (b)(6), 2016 where it was reported that the device lost power during use and the ball bearing, spring seal, needle bearing, semi-circle bearing, vespel sp-22 sleeve bearing, d.C.Motor, and divers were replaced.This is not a related issue.Initial qa inspection of the electric dermatome by medicrea on (b)(6) 2017 revealed that the motor was out of service.The cable and the reciprocating arm were damaged.Repair of the electric dermatome was not performed by medicrea as the customer has not response about the repair.The reported event was confirmed since during initial inspection the motor was out of service.The root cause of the device loss power during use was due to the motor being out of service.The cause of the motor being out of service cannot be specifically determined with the provided information.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
• 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: 6745406
• MDR Text Key: 81111907
• Report Number: 0001526350-2017-00437
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 63138622
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2015
• 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
• Patient Outcome(s): Required Intervention