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

Model Number 00-8801-002-00

Device Problem Fitting Problem (2183)

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

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.

Event Description

It was reported that prior to surgery the hose would not connect to multiple adapters.There was a 45 minute delay.However, there was no harm and no medical intervention.No adverse events were reported as a result of this malfunction.No further information is available.

Event Description

No further information is available at this time.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Functional testing of the returned product identified the hose would not fit onto the air dermatome.Visual inspection found the hose connector dimensions measured within specification and no non-conformities were 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 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.

• Brand Name: DERMATOME HOSE
• Type of Device: PNEUMATIC HOSE
• 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: 15889039
• MDR Text Key: 307808804
• Report Number: 0001526350-2022-01155
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375918
• UDI-Public: (01)00889024375918(11)220801(10)65592975
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-8801-002-00
• Device Catalogue Number: 00880100200
• Device Lot Number: 65592975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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