MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GD WIRE NITINOL 1.2 X 45CM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	72202998
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a hip arthroscopy surgery by inserting the nitinol wire and placing the cannula on the wire, it broke.It was removed with grasper.No backup device was available to complete the procedure and no delay or patient injuries were reported.
Additional Manufacturer Narrative
One 72202998 disposable nitinol guide wire product used for treatment but was not returned for evaluation.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were limited 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: getting entangled up with other instruments or devices.Use of other than recommended smith and nephew drill.The primary cutting edges of the drill are not sharp or have dings and burrs.Stressed product from over torque or loss of axial alignment.Review of instruction for use (ifu) documentation confirms instructions, precautionary statements and recommendations for proper use of product.Per ifu: ¿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 predetermined specifications upon release to distribution.
Additional Manufacturer Narrative
One 72202998 nitinol guide wire used for treatment, was returned for evaluation.The complaint stated: ¿by inserting the nitinol wire and placing the cannula on the wire, it broke.¿ the wire was returned in two sections.A piece approximately 2 inches long was fractured off.These wires are intended to flex but not be bent.The condition indicates the wire was snapped from having excess torque or leverage applied.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.Getting entangled up with other instruments or devices.2.Stressed product from over torque or loss of axial alignment.3.Use of other that recommended smith and nephew drill.4.The primary cutting edges of the drill are not sharp or have dings and burrs.Instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Per instructions for use: ¿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¿.No root cause related to the manufacture of this device was confirmed.

• Brand Name: GD WIRE NITINOL 1.2 X 45CM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8815951
• Report Number: 1219602-2019-00857
• Device Sequence Number: 14040475
• Product Code: LXH
• UDI-Device Identifier: 00885554017670
• UDI-Public: 00885554017670
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2019

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: 11/26/2023
• Device Catalogue Number: 72202998
• Device Lot Number: 2024869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/22/2019; 10/31/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/25/2019; 11/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR