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 Unexpected Shutdown (4019); Intermittent Energy Output (4025)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Concomitant med products: battery devices and casing devices.The manufacturing location was unknown.Device manufacture date was unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the battery oscillator device functioned with the power switch on/off, then ceased immediately and did not respond.According to the user, the device power felt weak from the beginning of the surgery.It was reported that there was a 30 minute delay in the surgical procedure and the surgery was continued by replacing the battery.It was reported that the device was being used with two battery devices and two casing devices.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

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 device date of manufacture and manufacture site name and address were documented as unknown in the initial report.The date of manufacture and manufacture site name and address have all been updated accordingly.The actual device was returned for evaluation.Quality engineering evaluated the device and observed that the device passed all manufacturing specifications.Therefore, the reported condition was not duplicated and confirmed.A review of the service history record indicates that the device had not been returned previously for the same malfunction.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 8961113
• MDR Text Key: 156583245
• Report Number: 8030965-2019-67958
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491847
• UDI-Public: 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: 08/23/2019

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: 09/11/2019
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1