MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RND ENDBTN POST SST W-SZ3/4 SUTURE LOOP; SCREW, FIXATION, BONE

Catalog Number	71934993
Medical Device Problem Codes	Migration (4003); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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, one week after a dislocation surgery was performed, on (b)(6) 2025, it was discovered on an x-ray that the round endobutton became dislodged due to loosening or rupture of the artificial ligament.A revision surgery was performed on (b)(6) 2025 to resolve this, during which a competitor device was used.Patient's outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H11 b2: updated.H3, h6: the reported device was received for evaluation.A visual inspection showed the device was not returned with original packaging.The endobutton has two partial white sutures threaded through that have been cut off.The button and sutures have no visible defect.Bio debris is present.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 no 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.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 clinical review states that per report, on december 11, 2025, one week following the patient¿s dislocation surgery, an xray revealed that the round endobutton had become dislodged due to loosening or rupture of the artificial ligament.The provided x-rays along with the intra-operative photo confirm the report; however, they do not aid in determining the root cause.The report stated that revision surgery was performed on (b)(6) 2025, using a competitor¿s device.A photo was provided that shows the removed endobutton.Consequently, the patient¿s outcome is unknown.All documents and images provided as of this date have been reviewed and considered, and unless noted, do not contribute to the clinical/medical investigation.Based on the limited information provided, the definitive clinical root cause of the reported migration could not be determined.Although a procedural variance vs user error could not be excluded as a potential contributory factor.As the ifu for the device does warn; ¿it is the healthcare professional¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ therefore, a causal relationship between the reported adverse event and the s&n device could not be established.The report stated this adverse event was resolved with revision surgery using a competitor¿s device; however, the patient¿s outcome is unknown.The impact on the patient beyond the revision could not be determined since the patient was revised to a competitor¿s device, and the outcome of the patient was not reported.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.Other factor lines include excessive force or torsion during use or use of sharp instruments near the device tip.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: RND ENDBTN POST SST W-SZ3/4 SUTURE LOOP
• Common Device Name: SCREW, FIXATION, BONE
• 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: 24188451
• Report Number: 1219602-2026-00240
• Device Sequence Number: 9600698
• Product Code: HWC
• UDI-Device Identifier: 00885556424544
• UDI-Public: 885556424544
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/06/2026

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: 71934993
• Device Lot Number: 48129-02B
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2025
• 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: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown