MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME II HOSE: UK MA-7 SCHRADER, 3 M

Catalog Number 00885100206

Device Problem Gas/Air Leak (2946)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001526350 - 2023 -01591.G2- event occurred in france.

Event Description

It was reported that during an unknown time on an unknown date, that there was a leakage at the coupling portion of the hose.The small o-ring did not make the seal.There was no information communicated regarding harm, injury, or delay.Due diligence is in progress.No additional information is available at this time.

Event Description

It was reported that before surgery that there was a leakage at the coupling portion of the hose.The small o-ring did not make the seal.There was no harm or injury to the patient and no reported delay.Due diligence is complete.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.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01590-2.No product was returned, only pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is not 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 II HOSE: UK MA-7 SCHRADER, 3 M
• 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: 18256433
• MDR Text Key: 329605474
• Report Number: 0001526350-2023-01590
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024376144
• UDI-Public: (01)00889024376144(11)220915(10)65636385
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2024

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 Catalogue Number: 00885100206
• Device Lot Number: 65636385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/22/2023; 05/13/2024
• Supplement Dates FDA Received: 12/27/2023; 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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: CATALOG # 00880100100SERIAL # (B)(6)
• Patient Sex: Prefer Not To Disclose