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

Catalog Number 88710100

Device Problem Misassembly by Users (3133)

Patient Problem Abrasion (1689)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that due to improper placement of the guide, the harvest of the donor site was much deeper than intended.The site required additional grafting.No other adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under(b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, g4, g7, h1, h2, h3, h6, h10.Reported issue: on (b)(6)2019 , it was reported that improper assembly could cause the width plate to be miss-aligned leading to patient injury.Per follow up: it was reported that the guide was improperly secured (human factor).Due to improper placement of the guide, the harvest of the donor site was much deeper than intended.The site required additional grafting.No injury to operator.Product will not be returned for investigation.The customer did not return a dermatome an device, serial number unknown, for evaluation.Dhr review: the device history record (dhr) review was unable to be performed as the device serial number is unknown.The customer did not provide a serial number during follow up.Device evaluations results/investigation findings: product review of the dermatome an was not performed as the device was not returned for repair or evaluation.Repair of the dermatome an was not performed as the device was not returned for repair or evaluation.To prevent or reduce the risk of the problem occurring: ensure that both tabs on the width plate of the dermatome an are properly seated in the locking mechanism; visually confirm that the tabs on the width plate are within the grooves on the head of the device, prior to securing the width plate screw.After securing the width plate screw, visually inspect the device to confirm the width plate is properly seated, parallel to the blade, and not on an angle.Train all users on the proper technique used to prepare the device for use.Probable cause/root cause: the reported event was never confirmed as the device was never returned for evaluation.Therefore, the root cause 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.Conclusion: 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

It was reported that the guide was improperly secured (human factor).Due to improper placement of the guide, the harvest of the donor site was much deeper than intended.The site required additional grafting.No injury to operator.Product will not be returned for investigation.

• 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: 9088339
• MDR Text Key: 160553495
• Report Number: 0001526350-2019-00788
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 88710100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention