MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS QUICK COUPLING FOR K-WIRES F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.790

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316)

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

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(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.

Event Description

This is event 1 of 3 for the same event.It was reported from (b)(6) that during a trochanteric fixation nail surgery, it was observed that the coupling device for k-wires was not holding the wires properly when used together.According to the reporter, the jaws on the device were probably too worn.It was further reported that the quick coupling device for drill bits had come apart and the battery casing device would not hold/secure the battery when used together.It was reported that there was an eight minute delay to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There was a medical intervention but it was not specified.There were no injuries or prolonged hospitalization.It was reported that the surgery was completed successfully.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 has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the unit was found not to be holding the 1.5mm wire.It was also noted that the clamps were worn, internal components were corroded, stop ring and guide sleeve were worn.Therefore, the reported condition was confirmed.The assignable root cause was determined to be from wear over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: QUICK COUPLING FOR K-WIRES F/BPL
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6245599
• MDR Text Key: 64731362
• Report Number: 8030965-2017-10175
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.790
• Device Lot Number: 2416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2008
• 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 CASING DEVICE; QUICK COUPLING DEVICE FOR DRILL BITS