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

Catalog Number 88710100

Device Problem Incorrect Measurement (1383)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Report source: (b)(6).Follow up to obtain additional information is in progress.Once the new information becomes available, a follow-up mdr will be submitted.

Event Description

It was reported that the device had cut deeper than what it was set for.No other information provided.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Udi no.(b)(4).On august 2, 2019, it was reported that the device cut deeper than it was set for.The customer returned a dermatome an device, 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.Zimmer biomet surgical has not previously repaired/evaluated dermatome an serial number 700489 as documented in the repair reports in livelink.Product review of the dermatome an on august 13, 2019 revealed that the device operated within motor speed specifications and was within calibration and side to side specifications at all tested thickness settings.The control bar was noted to not be in the correct position.No other problem was found with the device.Repair of the dermatome an was performed by zimmer biomet surgical on august 13, 2019 which included replacement of the vespel and semi-circle bearings.The control bar was also set to the correct position.Dermatome an, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The cause of the reported event was due to the control bar not being located in the correct position.If the control bar is low it could cause the device to gouge the patient.If the control bar is high it could lead to the device skipping across the skin.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.Review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the device had cut deeper than what it was set for.During surgery the patient had a full thickness graft taken rather that a split thickness graft.There was no surgical delay and an additional graft was not required.No adverse events were reported as a result of this malfunction.

• Brand Name: DERMATOME AN HANDPIECE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8869749
• MDR Text Key: 154318193
• Report Number: 0001526350-2019-00631
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 88710100
• Device Lot Number: 64310248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1