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

Model Number N/A

Device Problems Dull, Blunt (2407); Failure to Cut (2587); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01028.G2: foreign country - sweden.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.

Event Description

It was reported that during surgery the blade that was placed in the dermatome did not cut evenly.It became like a left stripe in the middle.The machine and blade were changed; however, the same thing occurred.Different doctors used the dermatome, but all get the same result.It is like the blade isn¿t straight in the middle or if it is not sharp in the middle of the blade.There was no harm or delay reported.No adverse events were reported as a result of this malfunction.Due diligence is in progress for this complaint.To date, no additional information or product has been received.

Event Description

There is no additional event information available.

Manufacturer Narrative

Following sections were updated or corrected: b1, b2, b4, b5, d2, g1, g3, g6, h1, h2, h6, h10, h7, h9, d4.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.

Manufacturer Narrative

Associated report was ran: 0001526350-2023-01028-2.No product was returned or pictures provided; functional, visual, and/or dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a manufacturing and design 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.

Event Description

There is no additional event information available.

• Brand Name: DERMATOME BLADES
• Type of Device: DERMATOME BLADE, SINGLE-USE
• 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: 17661234
• MDR Text Key: 322387487
• Report Number: 0001526350-2023-01027
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375895
• UDI-Public: (01)00889024375895(17)280219(10)65925347
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• 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: 65925347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose