MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 4.0MM THREE-FLUTED RADIOLUCENTDRILL BIT/BRAD; BIT, DRILL

Catalog Number 511.417

Device Problem Mechanical Problem (1384)

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

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

Udi - (b)(4).Device manufacture date: the device manufacture date is unavailable.The manufacturing location was unknown.Reporter's phone number: (b)(6).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 7 for the same event.It was reported from (b)(6) that during a surgical procedure for femur sub-trochanteric and trochanteric fractures it was observed that while performing distal screw locking using a pfna (proximal femoral nail antirotation) long nail, the physician could not drill the bone with the radiolucent drive device.It was reported that six drill bit devices were also used in the procedure.The reporter stated that the device seemed to have weak torque.It was reported that there was 30 minute delay in the procedure due to the event, and an unspecified spare device was available for use.It was reported that the procedure was successfully completed, without using the radiolucent drive device.It was reported that the product/instrument was not broken during surgery.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no 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 returned to manufacturer was documented as december 6, 2016 in the initial report and has been updated to december 16, 2016.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.Device evaluation: 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 and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 4.0MM THREE-FLUTED RADIOLUCENTDRILL BIT/BRAD
• Type of Device: BIT, DRILL
• 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: 6230527
• MDR Text Key: 64132177
• Report Number: 8030965-2017-10135
• Device Sequence Number: 1
• Product Code: HTW
• 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
• Report Date: 11/02/2016

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: U175949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: DRILL BIT DEVICES; PFNA LONG NAIL DEVICE; RADIOLUCENT DRIVE DEVICE