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

Catalog Number 00882100100

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record for zimmer electric dermatome serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with the device.The record review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on (b)(4) as well as sap to query for all repairs on serial number (b)(4) prior to 13 june 2019, the device was noted to have not been previously repaired.Review of the complaint history based on the above keywords found no other similar events related to the reported device; as such, no further additional action is required at this time.The reported event was confirmed by the service technician who performed the evaluation and repair.On 13 june 2019, it was reported during preventative maintenance a dermatome had a defective needle bearing and e-rings and had a motor issue.A zimmer electric dermatome serial number (b)(4) was already at the site and was available for evaluation.Evaluation of the device found that the needle bearing and the e-rings on the dermatome were defective and the motor was found to have been seizing and warm.It was recommended to replace the needle bearing, e-rings, motor, washers, and screws on the device.At the time of the investigation, the device was put on a quotation hold due to the motor seizing during final testing.The device was tested and inspected.While the service technician found that the needle bearing, e-rings, and the motor were all defective, it cannot be determined from the information provided as to what caused the defectives with each of the components.Therefore, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.

Event Description

It was reported that during pm, it was found that the defective needle and defective e-rings was replaced and had motor issue.Investigation findings revealed the motor was seizing and warm.

• 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: 9119018
• MDR Text Key: 160065425
• Report Number: 0001526350-2019-00811
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• 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: 32325100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1