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

Model Number N/A

Device Problems Failure to Cut (2587); Patient Device Interaction Problem (4001)

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

Event Date 07/26/2023

Event Type  Injury  

Event Description

It was reported that during surgery on (b)(6) 2023, the graft cut was incomplete.Another dermatome was requested.The donor site on the patient was noted to have intact skin in the middle of the site indicative of the dermatome blade not engaging the skin.The skin from the pass was also torn and did not come off in one uniform piece.There was a patient involved and permanent harm was reported.Due diligence information in progress.No additional information available at this time.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.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 during the procedure the surgeon went to harvest the graft, and the cut was incomplete.Another dermatome was requested.The donor site on the patient was noted to have intact skin in the middle of the site indicative of the dermatome blade not engaging the skin.The skin from the pass was also torn and did not come off in one uniform piece.The procedure was aborted, and an additional surgery occurred seven days later.An additional unplanned graft was taken.Due diligence information complete.No additional information is available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Associated report for blade: 0001526350-2024-00246.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 related to the reported event.A definitive root cause cannot be determined.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: 17914181
• MDR Text Key: 325412316
• Report Number: 0001526350-2023-01314
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• 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: 62689593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: UNKNOWN BLADE
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Prefer Not To Disclose