MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY REAMER/DRILL FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.705_XX

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during a training course it was observed that the battery reamer/drill device was getting very hot and stopped running.This event did not occur during surgery.There was no patient involvement.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 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.Device was used for treatment, not diagnosis.Service review: a review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.The actual device was returned for evaluation.The battery reamer/drill device was evaluated and the reported condition that the device was getting hot and stopped running was confirmed.An assessment was performed and it was observed that the device was getting hot and making an unusual noise, the markings were faded.The reported condition that the device intermittent/stops working was not confirmed.During repair it was observed that the electronic control unit (ecu) and motor were worn, and there was an unknown debris inside the gear components.The assignable root cause was determined to be due to wear from normal use over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: BATTERY REAMER/DRILL 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: 8104690
• MDR Text Key: 128389825
• Report Number: 8030965-2018-58466
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819491830
• UDI-Public: (01)7611819491830(11)131104
• 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
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.705_XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1