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

Catalog Number 530.710

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during a knee surgery, it was discovered that the battery oscillator device became ¿super¿ hot in the operating room (or) and was unable to be held.It was not reported if there were any delays in the surgical procedure or if spare device was available for use.There was patient involvement reported.There were no 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

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.A visual and functional assessment was performed on the device which found that the oscillating head was cracked (design issues) and the device was running hot (normal wear).During service/repair, it was determined that the unit's ecu (electronic control unit) wire contacts were corroded and other components were worn (normal wear).It was determined that the device was corroded with some debris on them.It was further determined that the issues were consistent with design issues and normal wear.The assignable root causes were determined to be due to design issues and normal wear out from use.This design issue has been escalated to capa.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

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.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent 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: 7430406
• MDR Text Key: 105546603
• Report Number: 8030965-2018-53072
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819491847
• UDI-Public: (01)7611819491847(11)151014
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2018

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: 530.710
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 05/24/2018
• Supplement Dates FDA Received: 04/24/2018; 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1