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

Model Number 89-8521-470-40

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - foreign: united kingdom.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 the aseptic battery housing opened during surgery.This event is related to a malfunction that could potentially lead to a sterility issue.Due diligence is in progress for this complaint; to date, whatever additional information received has been included in this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated:b4, b5, g3,g6, h2, h6, h10 dhr review was performed.Device was 8 months old and is not out of box failure.The device was not returned for repair/evaluation.Device is used for treatment.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental 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: 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: 15666118
• MDR Text Key: 306936631
• Report Number: 0008031000-2022-00041
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 00889024581746
• UDI-Public: (01)00889024581746(11)220204(10)5015978
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/23/2023

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: 89-8521-470-40
• Device Catalogue Number: 89-8521-470-40
• Device Lot Number: 5015978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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