MAUDE Adverse Event Report: SMITH & NEPHEW, INC. Q-FIX KNTLS ASA 1.8MM W/1 UB SUT CB-BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205883
Medical Device Problem Codes	Break (1069); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks 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 conservatively 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 hip arthroscopy procedure, while two (2) q-fix knotless anchors were being used, it was noticed that the black marks on the distal end of the cobraid blue repair stitch were more proximal than normal, with the last black line ending at the 9 inches down the repair stitch vs.The standard 4 inches.For the first q-fix knotless anchor (b)(4), the cobraid blue repair stitch was being loaded at the last black mark which ended up being right where the size 2-0 to #2 junction was of the repair stitch.While the repair stitch was being shuttled through the anchor using the black and white transfer stitch, the excess friction of the #2 end of the repair suture caused the transfer stitch to break during shuttling.The repair stitch had already been shuttled through the anchor, so the surgeon was able to grab the repair stich limb with a grasper down the clear-trac cannula and complete proper tensioning.For the second q-fix knotless anchor (b)(4), the surgeon ignored the black lines and loaded the repair stitch at the 4-inch point on the distal end of the repair stitch.The anchor preformed fine.A different lot (2168841) was used after realizing that two anchors of the lot 2169130 had an incorrect placement of the black marks, and both anchors of lot 2168841 had the correct distal placement of the black marks (4 inches).Both anchors with the incorrect placement of the black marks were successfully implanted into the patient.There was no surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not received for evaluation.However, three unopened/sealed devices were each returned in original packaging with the batch number of the complaint on the labels.A visual inspection of these devices revealed there is no visible defect on the outer device.All three devices were checked for the black indicator suture on the repair suture.All three of the devices black indicator suture began at, or more than, four inches of suture length.A material assessment could not be performed due to the used transfer stitch not being returned for evaluation.A dimensional evaluation using a digital caliper (b-com-001) was used to measure the black tracer thread which should start at 0.0 of the proximal tip of the repair suture and be a length of 4.0 ±.5 inches per drawing.Device one started at approximately 4.1 inches from the proximal end of the suture.Device two's black tracer thread started at approximately 4.0 inches from the proximal end of the suture.Device three's black tracer thread started at approximately 4.4 inches from the proximal end of the suture.A complaint history review found a similar reported event.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 review of the assembly device document found that the assembler must visually verify the presence of the implant¿s knot, ensuring it is placed in a flush position with the distal end of the driver tube.The implant¿s knot can be 1 millimeter outside the distal end of the driver tube and also verified with a gage if necessary.The implant¿s knot can be 1.5 millimeters inside the distal end of the driver tube.A review of the suture specifications found that the diameter must be 0.275 in, and the knot pull strength must be 6.20 lbf.Each shipment of material must be accompanied by the manufacturer´s certificate of conformance.A review of historical escalations found a manufacturing issue related to the distance between the black marks.The root cause of the reported event has been traced to a supplier manufacturing issue, which resulted in the black tracer on the suture being located 4 inches further down the suture.The important design feature is the location of the transition between black tracer and no black tracer, which remains in the same location in either instance.A corrective action was previously initiated to address this issue.

• Brand Name: Q-FIX KNTLS ASA 1.8MM W/1 UB SUT CB-BL
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21389111
• Report Number: 1219602-2025-00368
• Device Sequence Number: 15584953
• Product Code: MBI
• UDI-Device Identifier: 00885556901694
• UDI-Public: 885556901694
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 72205883
• Device Lot Number: 2169130
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2024
• 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 Sex: Unknown