MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOSCOPIC CANN DRILL BIT 6MM; CULDOSCOPE (AND ACCESSORIES)

Catalog Number	013499
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction after a guide wire was inserted into femoral bone, the surgeon used the over drilling to make the femoral tunnel, but it was hard to drill.When the guide wire was reinserted, the guide wire broke.No back-up device available and it is unknown if there was delay in the procedure.
Additional Manufacturer Narrative
One 013499 endoscopic cannulated 6mm drill bit was returned for evaluation.The complaint stated: ¿after a guide wire was inserted into femoral bone, the surgeon used the over drilling to make the femoral tunnel, but it was hard to drill.When the guide wire was reinserted, the guide wire broke.¿ the drill was received with a blockage inside the cannula.There is external damage; the cutting surfaces are scratched, gouged and dulled.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in the instrument¿s failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.Bowed or bent guidewires have been found to be a factor for this condition as well.Smith and nephew guide wires are intended for use with this drill bit.It is unknown whether the guidewire was a smith and nephew product.Request for information was unsuccessful.No root cause related to the manufacture of the device was confirmed.There are no other complaints for this manufacturing lot.No further investigation is warranted at this time.
Additional Manufacturer Narrative
Complaint revisit request.Request was asked to determine what was inside the drill lumen.Sectioning of the drill bit was performed.A 23.84mm section of a spade tip guide wire was retrieved from the lumen.The spade tip is of unknown origin.Post section inner diameter had scratches and fine debris were left behind from the jammed instrument.There was no other obstruction or material observed.Smith and nephew guide wires are intended for use with this drill bit.We do not support use of other than smith and nephew products with each other.

• Brand Name: ENDOSCOPIC CANN DRILL BIT 6MM
• Common Device Name: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8495745
• Report Number: 1219602-2019-00401
• Device Sequence Number: 19505404
• Product Code: HEW
• UDI-Device Identifier: 03596010090850
• UDI-Public: 03596010090850
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2019

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 Catalogue Number: 013499
• Device Lot Number: USW55060/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/26/2019; 06/06/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 04/29/2019; 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1