MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE WIRE,1.5MMX12"(PK OF 1)STERILE; PASSER

Catalog Number 014859

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

It was reported that during acl procedure, the k wire device was acting as guide wire.The k wire snapped and fragment is embedded in femoral bone.Despite several attempts to get more information regarding the procedure and the patient condition, no response has been received from reporter.

Manufacturer Narrative

One 014859 sterile 1.5mmx12¿ guide wire reported on.Product was not returned for evaluation.The complaint stated: ¿it was reported that during acl procedure, the k wire device was acting as guide wire.The k wire snapped and fragment is embedded in femoral bone.Despite several attempts to get more information regarding the procedure and the patient condition, no response has been received from reporter.¿ 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: use of other that recommended smith & 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; the wires are intended to flex vs.Bend.Getting entangled up with other instruments or devices.Final product met predetermined specifications upon release to distribution.

• Brand Name: GUIDE WIRE,1.5MMX12"(PK OF 1)STERILE
• Type of Device: PASSER
• 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: 8040032
• MDR Text Key: 126366693
• Report Number: 1219602-2018-01498
• Device Sequence Number: 0
• Product Code: HWQ
• Reporter Country Code: UK
• PMA/PMN Number: K920621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2023
• Device Catalogue Number: 014859
• Device Lot Number: 50716514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• 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