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

Model Number	72202998
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy when passing the wire through the needle, the guide wire broke inside the patient.Broken pieces were removed from the patient using tweezers.The procedure was completed with a backup device with no delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 1.2mmx45cm nitinol guidewire intended for use in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, 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 applied during use.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the complaint and manufacturing records was performed and there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.
Additional Manufacturer Narrative
H10: one 72202998 nitinol guide wire used for treatment, was returned for evaluation.The wire was returned broken into three sections.Pieces were visibly bent.These wires are intended to flex but not be bent.The condition indicates the wire was snapped from having excess force, 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: 9.Getting entangled up with other instruments or devices.10.Stressed product from over torque or loss of axial alignment.11.Use of other that recommended smith and nephew drill.12.Drill tip primary cutting edges were not sharp, had dings or burrs.Instruction for use documentation contains 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¿.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.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: 9378844
• Report Number: 1219602-2019-01486
• Device Sequence Number: 3067200
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2020

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: 04/11/2024
• Device Model Number: 72202998
• Device Catalogue Number: 72202998
• Device Lot Number: 2031405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/06/2020; 05/07/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/07/2020; 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR