MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS DRILL BIT Ø4 W/CENTER-TIP L148/122 3FLUT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 511.417

Device Problem Device Stops Intermittently (1599)

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

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 2 for the same event.It was reported from (b)(6) that during a surgical procedure for humeral diaphysis fracture to apply (b)(6) proximal femoral nail antirotation (pfna) blade-long device, it was observed that the radiolucent drive device stopped spinning the drill bit device while the surgeon was performing the distal locking.It was reported that the event occurred when the tip of the drill bit device came into contact with the opposite side of the proximal cortical bone after drilling and penetrating the proximal cortical bone of the patient's femur.It was reported that the distal locking procedure was completed by attaching the drill bit device directly to the power tool device.It was reported that there was a five minute delay in the surgical procedure.It was not reported if a spare device was available for use.It was reported that there was no alleged malfunction against the pfna (proximal femoral nail antirotation) device.There was patient involvement reported.It was not reported if there were any injuries, medical intervention or prolonged.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(4).The previous report stated the lot number as unknown.It has been updated to reflect the actual lot number (u135909).The manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4).Contact office name/address have been updated accordingly to reflect the corrected manufacturing facility.The previous report stated the date of manufacture (dom) was unknown.It has been updated to reflect the date (nov 15, 2011) the device was manufactured.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 confirmed.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 report will be submitted accordingly.

• Brand Name: DRILL BIT Ø4 W/CENTER-TIP L148/122 3FLUT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• 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: 5940195
• MDR Text Key: 54782569
• Report Number: 8030965-2016-14767
• Device Sequence Number: 1
• Product Code: HWE
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.417
• Device Lot Number: U135909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/12/2016; 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: POWER TOOL DEVICE; PROXIMAL FEMORAL NAIL ANTIROTATION; RADIOLUCENT DRIVE DEVICE