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

Catalog Number 530.710

Device Problems Complete Loss of Power (4015); Intermittent Loss of Power (4016); Excessive Heating (4030)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Concomitant med products and therapy dates: battery device, (b)(6) 2019.The reporter¿s complete facility address was not provided.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that during a total knee arthroplasty (tka) surgical procedure, it was discovered that the main body of the battery oscillator device became hot immediately after the surgery was started and ceased to function.It was reported that after that, the device started working; however, it became hot again and the user could hardly cut.It was reported that even though the battery device was replaced, the issue was not resolved.There was a thirty-minute delay to the surgical procedure.A spare device was available to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Correction: device availability: d10: the device availability date was incorrect in the initial report.The date has been updated from 12/17/2019 to 1/9/2020.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.Quality engineering evaluated the device.The device was evaluated, and the reported condition that the device was heating and worked intermittently was not confirmed.Therefore, an assignable root cause was not determined.However, during repair, it was determined that the electromotor oscillator silicone-treat was not working, and the handpiece was not working at all.It was further determined that the motor was damaged and would not run.It was further determined that the device failed for functional test.Therefore, the reported condition that the device stopped by itself was confirmed.The assignable root cause was determined to be traced to component failure, which is normal wear (faulty parts).If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATTERY OSCILLATOR II FOR BPL II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9528430
• MDR Text Key: 190677596
• Report Number: 8030965-2019-71251
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491847
• UDI-Public: 07611819491847
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• 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: 01/09/2020
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1