MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE WIRE 1.2MM X18 BX OF 5 STER.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72201201
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch report number: 1901760000-2020-8038.
Event or Problem Description
It was reported that during right acl procedure, the guide wire broke off at the tip while trying to insert softsilk screw in femur.Tip was retrieved from knee and was confirmed via x-ray that no remaining part were in patient.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: g4, h2, h3, h6.The reported device, used in treatment, was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.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.The guide wire 1.2mm x18 bx of 5 ster.Instructions for use warns, ¿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." a review of the guide wire 1.2mm x18 bx of 5 ster.Risk management files was performed and found multiple line items addressing this failure mode.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: GUIDE WIRE 1.2MM X18 BX OF 5 STER.
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10787996
• Report Number: 1219602-2020-01768
• Device Sequence Number: 19867343
• Product Code: LXH
• UDI-Device Identifier: 03596010587671
• UDI-Public: 03596010587671
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2021

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: 08/23/2024
• Device Model Number: 72201201
• Device Catalogue Number: 72201201
• Device Lot Number: 2039294
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 04/10/2021
• 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
• Patient Age: 19 YR