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

Catalog Number 530.705

Device Problem Failure to Shut Off (2939)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2015

Event Type  malfunction  

Event Description

It was reported that during pre-surgery, it was observed that the battery reamer/drill device continued to run after the trigger had been released.There were no delays in the surgical procedure as an identical spare device was available for use.There was no patient involvement reported.There were no 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

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not duplicated nor confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was observed that the device failed torque test.The assignable root cause was determined to be due to various worn components and seal deterioration from immersion during cleaning.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BATTERY REAMER/DRILL FOR BPL II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4573704
• MDR Text Key: 5555108
• Report Number: 3009450871-2015-10534
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1