MAUDE Adverse Event Report: SMITH & NEPHEW, INC. Q-FIX WITH NEEDLES - MINITAPE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205695
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during an ankle arthroscopy, the outer sheath of the metal tip of a q-fix broke off inside the patient's bone.The piece remained inside the patient.The procedure was resumed, after a non-significant surgical delay, using the same device.No further complications were reported.
Additional Manufacturer Narrative
H11 h3, h6 the reported device was not returned to the designated complaint unit for independent evaluation.However, a clinical review states that two intra-operative photos show the device in use.An intra-operative image confirmed that the broken piece appears within the fibula from this single view but cannot confirm it¿s within the bone on a single view.The chart stickers identifying the q-fix device used in the procedure were provided.Based on the information provided, the definitive root cause of the reported adverse event cannot be determined.However, user error versus procedural variance cannot be ruled out.The ifu warns: ¿it is the healthcare professional¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ the outer sheath of the metal tip of a q-fix is an externally communicating device that is neither manufactured nor intended for implantation.It is also not approved for long-term internal tissue exposure, and long-term implantation data is not available.Micro-motion or migration is unlikely, as it was reported that the outer sheath of the metal tip of a q-fix was left in the patient¿s bone.The potential impact to the patient includes risk of tissue inflammation, infection, pain, and prolonged surgery.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Factors that could have contributed to the reported event include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: Q-FIX WITH NEEDLES - MINITAPE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23532473
• Report Number: 1219602-2025-02815
• Device Sequence Number: 9140907
• Product Code: MBI
• UDI-Device Identifier: 00885556885642
• UDI-Public: 885556885642
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K231376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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 Catalogue Number: 72205695
• Device Lot Number: 2184974
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/23/2025
• Date Device Manufactured: 06/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Sex: Male