MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME, LINE-POWERED

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abrasion (1689); Scar Tissue (2060); Impaired Healing (2378)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are as follows: review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.The event cannot be confirmed.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during surgery the screw fixing the blade was found to be loose, resulting in the skin pieces taken being too thick, the skin removal area being deeper and difficult to heal, and scarring, hair thinning and even baldness after healing.Another device used to complete/finish the surgery.No additional unplanned skin graft.No additional information is available from the hospital.No additional patient consequences were reported.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME, LINE-POWERED
• 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14830176
• MDR Text Key: 295038119
• Report Number: 0001526350-2022-00552
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• 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: 63138503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2015
• 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
• Patient Outcome(s): Other