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 Type  malfunction  

Event Description

It was reported that the locking latch became broken during surgery.This event is related to a malfunction that could potentially lead to a sterility issue.Patient outcome unknown.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Report source: foreign ¿ france.The device was not returned for complaint investigation.The device could not be visually inspected in an effort to confirm the defect.Device is used for treatment.A root cause can 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: 15876027
• MDR Text Key: 307774059
• Report Number: 0008031000-2022-00050
• Device Sequence Number: 1
• Product Code: MOQ
• 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: Physician
• Type of Report: Initial
• Report Date: 11/29/2022

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: 89-8510-440-10
• Device Lot Number: 5014858
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2021
• 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