MAUDE Adverse Event Report: ZIMMER SURGICAL SA X SERIES ASEPTIC BATTERY HOUSING

Catalog Number 89-8521-470-40

Device Problems Mechanical Problem (1384); Vibration (1674)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the x-series single trigger handpiece was vibrating enough that the x-series aseptic battery housing came open in the middle of case.They switched to the sterilizable battery and upon attachment of all three batteries none would work.All batteries were returned to the charger and all were fully charged and not showing any error messages.The following report is relative to the x-series aseptic battery housing part number 89-8521-470-40 that opened during surgery.The lot number was not communicated by the customer.A follow up is on going to have information regarding the aseptic battery housing.The event occurred during surgery in the sterile area.There was no harm or injury to patient/operator reported.

Event Description

It was reported that the x-series single trigger handpiece was vibrating enough that the x-series aseptic battery housing came open in the middle of case.They switched to the sterilizable battery and upon attachment of all three batteries none would work.All batteries were returned to the charger and all were fully charged and not showing any error messages.The following report is relative to the x-series aseptic battery housing part number 89-8521-470-40 that opened during surgery.The lot number was not communicated by the customer.The event occurred during surgery in the sterile area.5 minutes of delay was reported to resolve the issue.There was no harm or injury to patient/operator reported.A follow was done to have information regarding the aseptic battery housing.No information was provided.

Manufacturer Narrative

(b)(4).After several attempts, the x-series aseptic battery housing part number 89-8521-470-40 was not returned for complaint investigation.Therefore it is not possible to confirm the reported event as product was not received.No device history record review could be performed as the batch number remains unknown.Another report will be performed if new information is received or if product is received.

• Brand Name: X SERIES ASEPTIC BATTERY HOUSING
• Type of Device: X SERIES 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: 12030967
• MDR Text Key: 260738560
• Report Number: 0008031000-2021-00018
• 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
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

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: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/11/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other