MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATTERY OSCILLATOR II HANDPIECE; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.710

Device Problem Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This is report 3 of 3 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the battery reamer/drill device did not stop after the trigger was switched off.According to the report, the alleged malfunction was observed in two battery reamer/drill devices and a battery oscillator device.There were no delays to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(6).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.

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed signs of heavy wear and tear.The sliding sleeve was pulled back and residues were found.It was further observed that there was visible humidity in the gear.Therefore, the reported condition was confirmed.It was determined that immersing the device in an aqueous solution or in an ultrasonic bath did not comply with instruction for use.The assignable root cause was determined to be due to improper maintenance which was user error, misuse and abuse.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 HANDPIECE
• 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: 4354690
• MDR Text Key: 5220908
• Report Number: 3009450871-2014-10883
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• 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: 12/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BATTERY REAMER/DRILL DEVICE; BATTERY REAMER/DRILL DEVICE