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 Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the saw head was detached from the handpiece and the oscillation head had a crack, the contacts of the device were corroded, and the device was in an overall worn condition.It was further determined that the device failed pretest for general condition, check saw blade coupling, check saw head ratchet, and trigger test.It was determined that the assignable root cause of the detached saw head and crack in the oscillating head was due to be improper construction and design and have been captured in a capa.The corroded contacts and general condition were determined to be traced to component failure due to normal wear.A review of the device history was performed and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi ¿ (b)(4).

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure of an unspecified joint it was observed that the oscillating saw device was found to be unstable during use.It was reported that the device was removed immediately from the patient area then disassembled into parts.It was reported that the interior part of the device was not in touch with the patient.It was reported that the device was not used in the procedure.It was reported that there was a 10-minute delay in the procedure due to the event.It was reported that an identical spare device was available for use and the procedure was successfully completed.There were no reports of injuries, medical intervention or prolonged hospitalization.During in-house engineering evaluation in switzerland it was observed that saw head was detached from the handpiece and the oscillation head had a crack.This event did not occur during surgery.The exact date of the event was not reported, however, it was reported that the event occurred in 2019.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): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9468044
• MDR Text Key: 195655221
• Report Number: 8030965-2019-71042
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491847
• UDI-Public: 7611819491847
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/13/2019
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1