MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.8 MM QUICK CONNECT DRILL BIT; PRSTHSSKNEEFEMRTIBLNNCNSTRINDCMNTDMTALPLYMR

Model Number	OR71563436
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, 4.8 mm drill seemed to ¿catch¿ in the bone when drilling the femur and caused the power tool to almost flip out of the surgeon¿s hand.As a result, the connecting end of the drill bit was severely twisted.No delay.No backup device available.No injury or impact to patient reported.
Additional Manufacturer Narrative
Results of investigation: the associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure modes.The fixation holes in the anterior cutting guide were damaged and the pin that mates with those holes was fractured.The drill was stuck in the drill guide.The chuck end of the drill was damaged.The quick connect and alignment rod had numerous nicks and scratches.The devices were manufactured in 2006, 2007 and 2008 and show signs of extensive wear / usage.The functional evaluation found the quick connect and alignment rod functioned as intended.The cutting guide would not accept a pin due to damage.The drill was stuck in the drill guide so it could not be evaluated.The medical investigation concluded that this complaint reports that when drilling the femur the 4.8mm drill ¿seemed to catch in the bone¿ and this severely twisted the drill bit causing the drill bit to be stuck in the im drill guide.While using the quick connector on reverse power the quick connect trocar pins ¿snapped¿ in the bone.Per communication, ¿the piece that had been in the bone was successfully retrieved.¿ the procedure was completed with no delay or patient injuries.No further assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The need for corrective action is not indicated.We consider this investigation closed.

• Brand Name: 4.8 MM QUICK CONNECT DRILL BIT
• Common Device Name: PRSTHSSKNEEFEMRTIBLNNCNSTRINDCMNTDMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9440689
• Report Number: 1020279-2019-04341
• Device Sequence Number: 11437163
• Product Code: HSX
• UDI-Device Identifier: 03596010573261
• UDI-Public: 03596010573261
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: OR71563436
• Device Catalogue Number: OR71563436
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 03/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71563409 JOURNEY ALIGNMT ROD LOT: 07EM13521; 71563439 JOURNEY DRILL GUIDE. LOT: 08BM14122