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

Model Number N/A

Device Problems Off-Label Use (1494); Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Date 03/12/2023

Event Type  Injury  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.

Event Description

It was reported that the complication occurred when an incorrect blade (integra dermatome) was placed in the zimmer dermatome.Event occurred during surgery on.It was reported the patient experienced unplanned lacerations.There was no reported delay.Due diligence is in progress, no further information is available at this time.

Event Description

No additional event information was provided.

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, d2, d4, d9, g1, g3, g6, h2, h3, h6 and h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, and lot identification was not provided.Review of complaint history found no additional related issues for this item and an additional search could not be completed as the lot # was unknown.Additional related reports: 0001526350-2024-00034.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: DERMATOME BLADES
• 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: 17340904
• MDR Text Key: 319239368
• Report Number: 0001526350-2023-00753
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• 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: 00880000010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Prefer Not To Disclose