MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

Model Number N/A

Device Problems Failure to Cut (2587); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Hair Loss (1877); Unspecified Tissue Injury (4559)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).E1 telephone number: (b)(6) g2 foreign: china evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that during surgery, dermatome thickness increased during grafts and the screws were found to have fallen out.There was damage to some hair follicles and skin was replanted with sutures and dressing.Due diligence information in process.No additional information available at this time.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that during surgery on (b)(6) 2024, dermatome thickness increased during grafts and the screws were found to have fallen out.A non zimmer blade was noted to have been used with the device.There was damage to some hair follicles and skin was replanted with unknown number of sutures and dressing.There was no additional skin graft required, no delay was noted and another device was used to complete procedure.Due diligence information complete.

Event Description

No additional event information available.

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, d4, g3, h2, h3, h4, h6, h11.Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a use issue.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER AIR 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19135574
• MDR Text Key: 340514386
• Report Number: 0001526350-2024-00466
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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: 00880100100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNK BLADE.; UNKNOWN NON-ZB BLADE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose