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

Catalog Number 530.630

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885); Electrical Shorting (2926)

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

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

Event Description

This is report 7 of 9 for the same event.It was reported that during a hemi hip replacement surgical procedure it was observed that the battery oscillator device blew the fuses of eight battery devices.It was reported that the eight battery devices showed a red light when seated in various battery charger devices.It was reported that the issue was discovered when the hospital set aside two handpiece devices suspected of damaging the batteries.The devices set aside were a battery oscillator device and a reamer device.During testing of the handpiece devices it was observed that the oscillator device was registering zero ohms and that the reamer handpiece was registering around 6-7k ohms.It was reported that there is no allegation of malfunction with the battery reamer linked to the shorting of batteries.It was reported that it is unknown if the oscillator device tested successfully during pre-surgery testing.It was reported that there was a 60 minute delay in the procedure, and the procedure was successfully completed.It was reported that there were no spare devices available.There were no patient or user injuries reported.It is unknown if there was any 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 date of this report was inadvertently reported as (b)(6) 2016 on the initial report.It has been updated as (b)(6) 2016 to reflect the correct information.The actual device was returned for evaluation.Reliability engineering evaluated the device.The external features of the device were visually inspected and it was determined that there was no evidence of abuse or manufacture issues.The device was tested and it was confirmed that the device was damaged.It was determined that the device had a blown fuse.Therefore, the reported condition was confirmed.It was determined that the root cause of the battery failure was due to excessive current that caused the battery to blow the fuse, suggesting that the battery had been connected to a device that had a short circuit.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATTERY FOR BATTERY POWER LINE II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5997758
• MDR Text Key: 57056394
• Report Number: 8030965-2016-15056
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BATTERY DEVICES; BATTERY OSCILLATOR DEVICE