MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCOPIC CANN 9MM; BIT, DRILL

Model Number 7209738

Device Problem Material Separation (1562)

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

Event Date 10/18/2019

Event Type  malfunction  

Event Description

It was reported that during case the clancy reamer broke in the bone tunnel, it was removed and use back up set to complete the procedure.No patient injuries or delay reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h6: one 7209738 flexible 9mm endoscopic cannulated drill used for treatment, was not returned for evaluation.This is a three year old reusable instrument.Due to unavailability, conclusions, investigation and evaluation were limited.If further information becomes available, the complaint may be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 1.Condition the driver¿s bit or chuck.2.Use of reverse rotation.3.Inadvertent torque, pressure, leverage and bending.4.Getting entangled up with other instruments or devices.5.Debris such as bone chips caught in the bit or chuck.6.Unexpected bone density/condition.Per instructions for use: ¿never use the drill in reverse rotation.Only use the drill in forward rotation.Using the drill in reverse rotation may result in patient injury and/or failure of the instrument.This is a limited reuse device based upon the sharpness of the drill tip.As with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument 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¿.This product is intended to flex but not be bent.Complaint history review indicated no similar allegations for the lot number reported.Dhr/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.No additional actions required at this time.

Manufacturer Narrative

The initial incident report was submitted with incorrect manufacturing site information and registration number (b)(4)(s+n (b)(6)).The correct manufacturing site information and registration number is (b)(4)(s+n (b)(6)).Corrected data: d3 and g1 manufacturing site name and address information.

• Brand Name: DRILL FLEXIBLE ENDOSCOPIC CANN 9MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048 6512
• MDR Report Key: 9302683
• MDR Text Key: 182995438
• Report Number: 1643264-2019-00766
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 03596010541994
• UDI-Public: 03596010541994
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7209738
• Device Catalogue Number: 7209738
• Device Lot Number: 50664852
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1