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

Model Number	7211138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a revision acl surgery that had been performed on (b)(6) 2020, the patient attended to 3-month follow up appointment with the surgeon.An x-ray was performed on (b)(6) 2020 and found broken wire in knee joint.A revision surgery was performed on (b)(6) 2020 to remove the broken guide wire.The patient outcome is unknown.
Additional Manufacturer Narrative
The reported 1.2mmx45cm nitinol guidewire, used in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.This case reports that during a revision procedure, the nitinol guidewire broke off in the knee joint.Approximately 4 months later the broken wire was confirmed on x-ray.Per email communication, it was reported that the broken wire was retrieved, however due to patient confidentiality no additional information will be provided.That patient's current status is unknown.From the information provided, the guidewire broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the device during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported device, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during a revision surgery performed on (b)(6) 2020 the 7cm long nitinol guide wire broke off during the insertion of tibia screw, also the guide wire was found broken in the knee joint.An x-ray was performed on (b)(6) 2020 and confirmed the broken wire in the knee joint.It was reported that a surgery was performed on (b)(6) in order to remove the broken device.

• Brand Name: GD WIRE NITINOL 1.2 X 45CM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10343653
• Report Number: 1219602-2020-01159
• Device Sequence Number: 13667873
• Product Code: LXH
• UDI-Device Identifier: 03596010559050
• UDI-Public: 03596010559050
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2018
• Device Model Number: 7211138
• Device Catalogue Number: 72202998
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/24/2020; 09/11/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/10/2020; 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention