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

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient Device Interaction Problem (4001)

Patient Problems Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Date 02/02/2023

Event Type  Injury  

Event Description

It was reported that: surgeon was using a dermatome for spit thickness skin grafting harvest.Dermatome was set at 0.12 with a 4 inch wide blade for harvest.Surgeon states that dermatome started harvest by completing harvest as planned, but as it proceeded, moved too deep and completed a full thickness skin graft, causing further patient injury.Medical intervention was needed as closure of defect created by dermatome needed to completed.Full thickness graft taken from surgical site required further attention for closure.Diligence is complete and 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.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the thickness control lever was loose.The planetary carrier, bearings, eccentric shaft, motor, and various other parts were scrapped and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is 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

No additional event information is available.

• Brand Name: ZMR AIR DERMATOME HANDPIECE
• 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: 16713374
• MDR Text Key: 313028625
• Report Number: 0001526350-2023-00359
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375901
• UDI-Public: (01)00889024375901(11)211215(10)65354789
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• 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: 00880100100
• Device Lot Number: 65354789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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
• Treatment: 00880100200DERMATOME HOSELN 65354789
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Male