MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCOPIC CANN 10MM; BIT, DRILL

Model Number 7209739

Device Problem Material Separation (1562)

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

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during an acl surgery, the 10mm clancy flexible drill broke inside the patient.Broken pieces were removed with tweezers.Then surgeon repeated the same technique with a new pin and reamer through a slightly different portal and it went perfectly from there.The procedure was successfully completed without significant delay and no patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3,h6: a 7209739 flexible 10mm endoscopic cannulated drill was used for treatment but was not returned.This item reported is a reusable instrument.The complaint was confirmed by the dr who said that his portal placement was too high and required the reamer/pin to bend too much.He later adjusted his portal and completed tunnel preparations with no incident.Physical evaluation was limited with no item returned.Factors that may affect device performance include: device ability, implant location and tissue condition.Review of instruction for use documentation contains precautionary statements and recommendations for proper use of product.Influences that could compromise product performance or integrity that are unrelated to manufacture include: 1) instrument blade dulling.Lack of recommended maintenance.2) entanglement with another instrument or device.3) incompatible force or torque applied.Per instructions for use: ¿this is a limited reuse device based upon the sharpness of the drill tip.Use of drills with that have worn or dull tips can result in breakage.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure¿.Complaint history review for three years prior indicated similar allegations for the product code reported.Batch review was unattainable without a valid lot number provided.Product met specifications upon release to distribution.

• Brand Name: DRILL FLEXIBLE ENDOSCOPIC CANN 10MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9720103
• MDR Text Key: 179741471
• Report Number: 1219602-2020-00227
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 03596010541970
• UDI-Public: 03596010541970
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7209739
• Device Catalogue Number: 7209739
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1