MAUDE Adverse Event Report: ZIMMER SURGICAL SA ASEPTIC TRANSFER KIT HOUSING; SURGICAL POWER TOOL BATTERY-EXCHANGE STERILITY COVER

Model Number N/A

Device Problem Mechanical Problem (1384)

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

It was reported that the battery casing was not possible to neither open or close after getting battery out.No patient involvement, as the event happened after surgery.This event is related to a malfunction that could potentially lead to a sterility issue/serious injury.However, no patient harm or further outcome was reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4), g2-foreign-canada.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Dhr review was performed.Device was 64 months old and is not out of box failure.Review of the device history record identified no deviations or anomalies during manufacturing.Upon receipt, the hinge on the housing was damaged and there was a leak.Review of complaint history identified additional similar complaints for the reported item.Complaints are monitored through monthly complaint review.No further action is required.A definitive root cause could not be determined.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: ASEPTIC TRANSFER KIT HOUSING
• Type of Device: SURGICAL POWER TOOL BATTERY-EXCHANGE STERILITY COVER
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17956304
• MDR Text Key: 325906894
• Report Number: 0008031000-2023-00030
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 00889024355149
• UDI-Public: (01)00889024355149(11)180525(10)5011123
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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 Model Number: N/A
• Device Catalogue Number: 89-8510-440-10
• Device Lot Number: 5011123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2018
• 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 Sex: Prefer Not To Disclose