MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE WR 1.2MM X 12 BOX OF 5 STERILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 7211138

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/22/2022

Event Type  Injury  

Event Description

It was reported that, during an acl procedure, the guidewire was placed for biosure regenesorb screw through the hamstring autograft, as opposed to adjacent to the graft.This caused the guidewire to get stuck in the acl tibial tunnel, and it presented in the joint space.An attempt to remove it with an artery was made, but this bent the guidewire.Then, a wire driver was used to try to back the guidewire out, which caused the wire to snap.It was necessary to snap the proximal part of the wire through the medial portal, thus leaving a section of it in the patients tibial tunnel.The procedure was completed with a non-significant delay but it is unknown how.No further complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.A complaint history review found similar reported events.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.This case reports the breakage of a guidewire and per report the broken guidewire was not able to be retrieved from the patient.No clinically relevant supporting documentation was provided for inclusion in a medical investigation.The guidewire is made of nitinol which is a biocompatible material however, since the guidewire is part of a surgical device it is not approved for implantation.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of the retained non-implantable foreign body fragments cannot be determined.No further medical assessment can be rendered at this time.The complaints were not confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, off-axis insertion of the device or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: GUIDE WR 1.2MM X 12 BOX OF 5 STERILE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14991353
• MDR Text Key: 295766579
• Report Number: 1219602-2022-01001
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010559050
• UDI-Public: 03596010559050
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7211138
• Device Catalogue Number: 7211138
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention