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

Catalog Number 530.710

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 01/01/2023

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: service review: a review of the service history record indicates that the device has been serviced within the last year for a service condition that is not relevant to the current reported condition.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition of the device having a broken oscillator head was not confirmed.Therefore, an assignable root cause was not determined.However, the saw head falling off, identified during service and evaluation was confirmed.It was determined that the issue related to the saw head was due to a design error, which has been escalated to a capa.All the other issues identified were due to component failure from wear.The assignable root causes were determined to be traced to component failure from wear and device design.Udi:(b)(4).

Event Description

It was reported by switzerland that during service and evaluation, it was determined that the saw head of the battery oscillator device fell off.It was found that the device passed visual inspection.It was further observed that the device would not run.It was further determined that the device failed pretest for check the quick coupling for saw blades, check positioning of saw head, check function of device and check oscillation frequency with frequency meter.It was noted in the service order that after surgery, it was observed that the oscillator head was broken.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2023.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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: 18587260
• MDR Text Key: 333844725
• Report Number: 8030965-2024-01398
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491847
• UDI-Public: 07611819491847
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1