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

Model Number N/A

Device Problems Problem with Sterilization (1596); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems Abrasion (1689); Laceration(s) (1946)

Event Date 06/08/2023

Event Type  Injury  

Event Description

It was reported that during surgery the dermatome skipped along the thigh and did not take an adequate graft.A new zimmer dermatome was brought to the room and that one had a hole in the wrapper.A third handpiece was brought to the room and was used on the patient with the same setting to complete the surgery.The patient now has a 3rd donor site that would not have been necessary if the first handpiece had worked.Additionally, the malfunction and the sterility issues added an extra hour of anesthesia and or time to this patient.Due diligence is in progress, no further information is available at this time.

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.Related reports:0001526350-2023-00770.

Manufacturer Narrative

Upon reassessment, this failure mode was identified to not be likely to cause or contribute to a serious injury if it were to reoccur and thus should not be considered a reportable event.Please consider the previous report void.This event was reported on mfr 0001526350-2023-00773 on july 20,2023.01/08/2024,.

Event Description

Upon reassessment, this failure mode was identified to not be likely to cause or contribute to a serious injury if it were to reoccur and thus should not be considered a reportable event.Please consider the previous report void.

• Brand Name: UNK 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: 17360943
• MDR Text Key: 319396541
• Report Number: 0001526350-2023-00773
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375901
• UDI-Public: (01)00889024375901(11)190918(10)64521846
• 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: Health Professional
• 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: 07/20/2023
• 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: UNK DERMATOME
• 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: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• 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 Age: 21 YR
• Patient Sex: Prefer Not To Disclose