MAUDE Adverse Event Report: ZIMMER SURGICAL SA ASEPTIC BATTERY HOUSING

Model Number N/A

Device Problem Use of Device Problem (1670)

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

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that housings pop open during surgery and having to tape them back.It was during surgery on a sterile field.This event is related to a malfunction that could potentially lead to a sterility issue.No patient outcome provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The device was not returned for complaint investigation as documented in the product retrieval task.The device could not be visually inspected in an effort to confirm the defect.The dhr was not reviewed as lot/serial number is required and is not provided.A definitive root cause cannot 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.

Event Description

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

• Brand Name: ASEPTIC BATTERY HOUSING
• Type of Device: ASEPTIC BATTERY HOUSING
• 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: 14565223
• MDR Text Key: 299370075
• Report Number: 0008031000-2022-00014
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 889024581746
• UDI-Public: (01)889024581746
• 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: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• 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: 89-8521-470-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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