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

Model Number	7209738
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported about a 9 mm flexible drill that, during an unknown procedure, broke while drilling the femoral tunnel.It is unknown if a back-up device was available or if there was a delay in the scheduled surgery.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h3, h6: one 7209738 flexible 9mm endoscopic cannulated drill used for treatment, was not returned for evaluation.This device was over 5 years old at time of use.It had exceeded its expiration.Due to unavailability, 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.Batch 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.

• Brand Name: DRILL FLEXIBLE ENDOSCOPIC CANN 9MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9664249
• Report Number: 1219602-2020-00164
• Device Sequence Number: 2756688
• Product Code: HTW
• UDI-Device Identifier: 03596010541994
• UDI-Public: 03596010541994
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 7209738
• Device Catalogue Number: 7209738
• Device Lot Number: 50502484
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1