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 Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

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, it was discovered that the battery oscillator was powerless, and it heated up.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in (b)(6) 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

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 determined that the coupling tool side was out of specification and the attachment was defective.It was further determined that the device failed pretest for functional test, check saw head ratchet, check saw blade coupling, and check for correct clamping nut (without bore).The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.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: 8310646
• MDR Text Key: 135195363
• Report Number: 8030965-2019-60654
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819491847
• UDI-Public: (01)7611819491847(11)170505
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• 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: 01/30/2019
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1