MAUDE Adverse Event Report: ZIMMER SURGICAL SA ASEPTIC BATTERY HOUSING

Catalog Number 89-8521-470-40

Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.

Event Description

It was reported that the aseptic battery housing, part number 89-8521-470-40, lot number 5014069 was opening up and exposing aseptic battery during a live case.This event is related to a malfunction that could potentially lead to a serious injury or sterility issue.As a result, a delay of 5 minutes was reported.There was no harm or injury to patient/operator reported.This event was reported for 6 aseptic battery housing, part number 89-8521-470-40, lot number 5014069, therefore 6 reports will be submitted.

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).This follow-up report is being submitted to relay device evaluation and corrected information in b5.Corrected information regarding section b5: the reported delay in surgery was 5-10 mins.Device evaluation: aseptic battery housing, part number 89-8521-470-40, lot number 5014069, was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the device had a locking system issue with the lid while applying excessive force.Device was not repairable and was recycled in zimmer biomet premises.The event reported by the customer was confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A summary of the investigation was sent to the complainant.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

It was reported that the aseptic battery housing, part number 89-8521-470-40, lot number 5014069 was opening up and exposing aseptic battery during a live case.This event is related to a malfunction that could potentially lead to a serious injury or sterility issue.As a result, a delay of 5-10 minutes was reported.There was no harm or injury to patient/operator reported.This event was reported for 6 aseptic battery housings, part number 89-8521-470-40, lot number 5014069, therefore 6 reports will be submitted.

• Brand Name: ASEPTIC BATTERY HOUSING
• Type of Device: ASEPTIC BATTERY HOUSIN
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12092579
• MDR Text Key: 259212875
• Report Number: 0008031000-2021-00027
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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: 89-8521-470-40
• Device Lot Number: 5014069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other