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

Catalog Number 89-8521-470-40

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that the lid hinge was broken.Even though the event did not take place during the surgery, it is related to a malfunction that could potentially lead to a sterility issue/serious injury.No patient harm or further outcome was reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).B3: no event date has been provided.G2- foreign: poland.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The device was not returned, so visual evaluation could not be performed.Device history record review was performed.Device was 14 months old and is not out of box failure.Review identified no deviations or anomalies during manufacturing related to the reported event.With given information, 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: 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: 18276736
• MDR Text Key: 329854021
• Report Number: 0008031000-2023-00064
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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: 5016765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2022
• 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