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

Catalog Number 530.710_XX

Device Problems Overheating of Device (1437); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.  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 the battery oscillator device was getting very hot and stopped running.This event did not occur during surgery.There was no patient involvement.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 will be submitted accordingly.

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition could not be confirmed since the device was not able to run.It was further determined that the device unit would not run/had no power, failed the safety assessment, needle bearing was corroded to guide sleeve, no rotation, had unusual noise and vibration and the electronic control unit had voltage output.A review of the service history record indicates that the device has been returned previously for an unrelated malfunction.The assignable root cause was determined to be due to improper maintenance and normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The date received by manufacturer was reported as jan 03, 2018 in the previous medwatch report.The correct date is jan 03, 2019.If additional information should become available, 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: 8104671
• MDR Text Key: 128389945
• Report Number: 8030965-2018-58482
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819491847
• UDI-Public: (01)7611819491847(11)130912
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.710_XX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1