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

Catalog Number 72201594

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/21/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8149304
• MDR Text Key: 129904000
• Report Number: 1219602-2018-01703
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010601452
• UDI-Public: 03596010601452
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Catalogue Number: 72201594
• Device Lot Number: 2007230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 02/18/2019
• Supplement Dates FDA Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1