MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE PASSING PIN 13.50 X 2.4MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72201594
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an acl surgery the 2.4mm flexible passing pin 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.
Additional Manufacturer Narrative
H10: h3,h6: a 72201594 flexible passing pin was used for treatment but was not returned.This product is sold as a 5 pack.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.These nitinol pins have ability to flex but not be bent.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.Other influences that may compromise performance or integrity include: 1 getting entangled up with other instruments or devices.2 condition the driver¿s bit or chuck.3 stripping or over-torque use.4 debris such as bone chips caught in the bit or chuck.5 unexpected bone density/condition.Per instructions for use: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.The reported wire snapped due to excess stress.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 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: FLEXIBLE PASSING PIN 13.50 X 2.4MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9720084
• Report Number: 1219602-2020-00226
• Device Sequence Number: 353280
• Product Code: NBH
• UDI-Device Identifier: 03596010601452
• UDI-Public: 03596010601452
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 72201594
• Device Catalogue Number: 72201594
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1