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

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problems Abrasion (1689); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/22/2023

Event Type  Injury  

Event Description

It was reported that during surgery on (b)(6) 2023 that the device was not attaching the hose; the cord was difficult to attach.There was no harm to the patient.A delay was reported but the duration is unknown.Another device was use to complete the procedure.Due diligence is complete and no additional information is available.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.A related mdr report was filled for this event, please see associated report: mfr - 0001526350-2023-00499.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record identified no repairs related to the reported event.The reported air hose attachment issue could not be confirmed; no problem found.The air hose was not returned with the device.Review of the device history record identified no deviations or anomalies during manufacturing.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.

Event Description

No additional information is available regarding the incident.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME HANDPIECE, PNEUMATIC
• 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: 17083563
• MDR Text Key: 317494563
• Report Number: 0001526350-2023-00550
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375901
• UDI-Public: (01)00889024375901(11)220428(10)65497068
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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: 65497068
• 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: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose