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 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

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.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 an unspecified surgical procedure, it was observed that the battery oscillator device was running hot.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no 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

The date device returned to manufacturer was documented as april 24, 2018 in the initial report.This has been corrected to april 23, 2018.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device sliding sleeve was found to be seized and would not slide back and forth to rotate the saw head ratchet, the device failed oscillating frequency, there was excessive corrosion on the internal sub assemblies, the thrust disk was worn, needle sleeve full load corroded, unknown liquid in the electronic control unit and the motor power contact was corroded.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear and from normal use and servicing and improper device maintenance which is user error/misuse/abuse.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): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7465289
• MDR Text Key: 106657915
• Report Number: 8030965-2018-53384
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819491847
• UDI-Public: (01)7611819491847
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.710
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Date Manufacturer Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1