MAUDE Adverse Event Report: SYNTHES GMBH BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.710

Device Problems Unintended Movement (3026); Complete Loss of Power (4015); Intermittent Loss of Power (4016)

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

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).

Event Description

It was reported from bulgaria that during a pre-surgery check, it was discovered that the battery oscillator device experienced interruptions during operation and the head rotated.The reporter clarified that the device exhibited intermittent operation, ceasing to function when under load.It was reported that there were no delays to the surgical procedure as an identical spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained, that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H6: service history review: the actual device was not returned for evaluation.Therefore, the reported condition was not confirmed.However, a service history review was performed.Which indicated, that the device was serviced over a year for a service condition that is not relevant to the current reported condition.

• Brand Name: BATTERY OSCILLATOR II FOR BPL II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 18212225
• MDR Text Key: 330009472
• Report Number: 8030965-2023-14881
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491847
• UDI-Public: 07611819491847
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.710
• Device Lot Number: 103165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1