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

Catalog Number	72201594
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ligamentplasty the flexible passing pin completely loosened the marks leaving the joint compartment full of fragments.There was a surgical delay greater than 30 minutes.No patient injury was reported.
Additional Manufacturer Narrative
One single 72201594 13.50x2.4mm flexible passing pin reported on.This product is sold as a 5 pack.These pins are intended to flex vs.Bend.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will 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: condition the driver¿s bit or chuck.Stripping or over-torque use.Getting entangled up with other instruments or devices.Debris such as bone chips caught in the bit or chuck.Unexpected bone density/condition.Per ifu: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ these wires are intended to flex but not bend.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.Final product met specifications upon release to distribution.There is no indication or anticipated patient injury as a result of this product incident.

• 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: 8149304
• Report Number: 1219602-2018-01703
• Device Sequence Number: 16515848
• Product Code: NBH
• UDI-Device Identifier: 03596010601452
• UDI-Public: 03596010601452
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Report Date (Section B): 02/25/2019

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 Expiration Date: 10/07/2022
• Device Catalogue Number: 72201594
• Device Lot Number: 2007230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1