MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME BLADES; DERMATOME BLADE, SINGLE-USE

Catalog Number 88700010

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Customer stated they will not be returning device due to blades not specific to the dermatome.Upon receipt of additional information and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that prior to surgery the customer was not able to fit the blade in the air dermatome handpiece.There was no report of harm to the patient and no delay reported as a result of this malfunction.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-0557820.The device history record (dhr) for the dermatome blade, part number 88700010, review could not be performed as a lot number was not provided for the reported event.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.However, it was noted in the reported event that the customer was attempting to use an 88700010 dermatome an blade with an air dermatome from the 8801 product family.The 88700010 blade can only be used with a dermatome an device due to the way it is attached to the head of the device.The reported event can be confirmed.The root cause of the reported event was due to the user attempting to attach a dermatome an blade to an air dermatome handpiece.The dermatome blade (ref 88700010) instruction manual notes "for use only with the dermatome models 8871, 8872, 8875 and 8876." the investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: DERMATOME BLADES
• Type of Device: DERMATOME BLADE, SINGLE-USE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9401076
• MDR Text Key: 197747705
• Report Number: 0001526350-2019-01098
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

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 Catalogue Number: 88700010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1