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 04/22/2022

Event Type  malfunction  

Event Description

T was reported that the aseptic battery housing part number 89-8521-470-40 lot number 5014308 the battery housing kept opening by itself during surgery.No harm to patient.No additional surgery.No delay this event is related to a malfunction that could potentially lead to a sterility issue.

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be performed if new information or product is received.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.1.Dhr review.Dhr review was performed.Device was 14 months old and is not out of box failure.2.Diagnosis data and analysis.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.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.

• Brand Name: ASEPTIC BATTERY HOUSING
• Type of Device: ASEPTIC BATTERY HOUSING
• 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: 14316347
• MDR Text Key: 299762528
• Report Number: 0008031000-2022-00009
• Device Sequence Number: 1
• Product Code: MOQ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

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 Catalogue Number: 89-8521-470-40
• Device Lot Number: 5014308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 07/04/2022
• Supplement Dates FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other