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 Dull, Blunt (2407); Output below Specifications (3004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

The reporter¿s phone number and complete address were not provided.The manufacturing site name and location were unknown.The serial number was unknown.Therefore, device manufacture date is unknown.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 from (b)(6) that during an unspecified surgical procedure, the surgeon discovered that the movement of the battery oscillator device was dull.There was a five minute delay to the surgical procedure.A spare device was used 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

Serial number: the device serial number was unknown in the initial report.Upon receipt of the device, the serial number was identified as (b)(4).The udi, date of manufacturer and manufacture site name and address have been updated accordingly.Device evaluation: 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 was confirmed.It was further determined that the trigger was blocked, jammed and was moving heavily.It was further determined that the locking ring of the trigger had become loose, preventing the trigger from being pressed to the end-stop position.As a result, the maximum speed could not be reached (lack of performance).It was further determined that the device failed pretest for trigger test, check the triggers and electronic control unit (ecu) function and check oscillation frequency 10800 - 14299 oscillation/minute.The assignable root cause was determined to be due to wear from normal use and servicing.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: 7268119
• MDR Text Key: 100266614
• Report Number: 8030965-2018-51081
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491847
• UDI-Public: (01)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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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: 03/09/2018
• Date Manufacturer Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1