MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WIRE GDE 2 FLT DRL.TIP 12; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7207221
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an arthroscopy the guide wire broke off inside the tibia.Surgeon unable to retrieve broken piece which now remains inside patient.The procedure was completed with the same device.No significant delay and no other complications were reported.
Additional Manufacturer Narrative
B5 and health effect - impact code updated.H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.This case reports the breakage of the guide wire inside of the patient¿s tibia, and the broken piece was not recovered from the patient.Therefore, we cannot rule out the possibility of micro-motion and/or migration and/or local irritation/discomfort.The guide wires are manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.The patient¿s x-rays requested were not provided.Additionally, it was communicated the surgeon used a backup guidewire to compare and it was revealed approx.1cm of the wire broke off inside patient.Based on the information provided, ¿the surgeon does not plan to remove the broken piece and the other surgeons agreed with him to leave it in¿.It was reported the patient is happy, healthy and there are no problems.Therefore, no further medical assessment can be rendered at this time.Should any additional relevant patient information be provided, this complaint would be re-assessed.A relationship, if any, between the subject device and the reported event could not be determined.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.
Event or Problem Description
It was reported that during an arthroscopy the guide wire broke off inside the tibia.Surgeon was unable to retrieve the broken piece which now remains inside patient and the surgeon does plan to remove it later.The procedure was completed with the same device since this was noticed at the end of the surgery.No significant delay and no other complications were reported.Currently, the patient is happy, healthy and with no problems.

• Brand Name: WIRE GDE 2 FLT DRL.TIP 12
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11828907
• Report Number: 1219602-2021-01142
• Device Sequence Number: 16409078
• Product Code: LXH
• UDI-Device Identifier: 03596010375322
• UDI-Public: 03596010375322
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 09/16/2025
• Device Model Number: 7207221
• Device Catalogue Number: 7207221
• Device Lot Number: 2061301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 11/04/2021
• 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