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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product has been returned to zimmer biomet, and the investigation is in process.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported by user unit is skipping.Event occurred during testing.No patient involvement or harm.No further event information available at the time of this report.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record identified no repairs related to the reported event.The reported cutting issue could not be replicated; no device problem found.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 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: 15770397
• MDR Text Key: 307771188
• Report Number: 0001526350-2022-01110
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100000
• Device Lot Number: 30875600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/1996
• 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