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

Catalog Number	72205695
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).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 a lateral collateral ligament knee reconstruction, the surgeon deployed the q-fix with needles after completing appropriate bone prep using the q-fix needles drill and universal extremities guide.After the surgeon has used needles to suture the minitape into the hamstring graft, the q-fix ball of suture pulls straight out.Nothing remained in the patient as we cut the anchor away from the graft post after it was pulled out of the bone.The procedure was resumed, with a delay of less than 30 minutes, using a 2.8 mm q-fix; therefore, they drilled over the original drill hole with a 2.8 mm drill.No further complications were reported.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual inspection revealed the device was returned in original packaging with the batch number of the complaint on the label.The anchor has been deployed with bio debris in it.Some of the anchor fibers are loose from the sutures being cut it.The needles and most of the sutures have been cut away.The cut away needles and sutures were not returned.The housing cover is off the insertion device and was not returned.The cleat is fully extended and locked.A functional evaluation was performed on the returned device and found the driver can no longer be used to advance the anchor as the spool cleat is fully extended from the body of the handle and the ratchet is locked.Based on the condition of the product material found during visual inspection, additional material testing is not required.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 found similar reported events.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.A clinical evaluation states that one photo of the device was provided for review; however, it does not indicate the clinical root cause.Based on the information provided, the clinical root cause of the reported events could not be determined, a user technique/procedural variance as a contributing factor to the reported event could not be ruled out.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (an inadvertent impact event that may have occurred during device transportation, rough shipping and handling, or at the customer site, as well as the application of an unintended, inappropriate, or excessive force to the device or contact with sharp instruments).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: 23677075
• Report Number: 1219602-2025-03030
• Device Sequence Number: 15698862
• Product Code: MBI
• UDI-Device Identifier: 00885556885642
• UDI-Public: 885556885642
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

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 Catalogue Number: 72205695
• Device Lot Number: 2180041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/30/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2025
• 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
• Patient Age: 43 YR
• Patient Sex: Male