MAUDE Adverse Event Report: ARTHROCARE CORPORATION MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72290001
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832)
Date of Event	12/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right rotator cuff surgery on (b)(6) 2024 in which a multifix s ultra was implanted, the patient experienced post-operative persistent severe pain that conditioned functional activities, requiring opioid analgesia and prolonged maintenance of tapentadol with a progressive increase in dosage.Physiotherapy treatment improved joint mobility, without resolution of the pain.Subsequent imaging showed subacromial bursitis.On (b)(6) 2024, an mri scan revealed that the multifix anchor was fractured into two fragments and displaced from its original position, which was confirmed on (b)(6) 2024 by an ultrasound scan.The patient underwent a revision surgery on (b)(6) 2024 to arthroscopically extract the suture anchor fragment.During the post-operative period, the patient showed a significant pain relief and resumed physiotherapy sessions after medical authorization.On (b)(6) 2025, the pain returned with functional worsening.On (b)(6) 2025, an mri confirmed the persistence of bursitis; treatment with platelet rich plasma (prp) was indicated and carried out on (b)(6) 2025.A bilateral mri was performed on (b)(6) 2025 and showed a reduction, but persistence, of inflammation in the right shoulder.The current health status of the patient is unknown.
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.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H2: additional information: b5 and h6: health effect - clinical and impact code.
Event or Problem Description
It was reported that, after a right rotator cuff surgery on (b)(6) 2024 in which a multifix s ultra was implanted, the patient experienced post-operative persistent severe pain that conditioned functional activities, requiring opioid analgesia and prolonged maintenance of tapentadol with a progressive increase in dosage.Physiotherapy treatment improved joint mobility, without resolution of the pain.Subsequent imaging showed subacromial bursitis.On (b)(6) 2024, an mri scan revealed that the multifix anchor was fractured into two fragments and displaced from its original position, which was confirmed on (b)(6) 2024 by an ultrasound scan.The patient underwent a revision surgery on (b)(6) 2024 to arthroscopically extract the suture anchor fragment.During the post-operative period, the patient showed a significant pain relief and resumed physiotherapy sessions after medical authorization.In (b)(6) 2025, the pain returned with functional worsening.In (b)(6) 2025, an mri confirmed the persistence of bursitis; treatment with platelet rich plasma (prp) was indicated and carried out on (b)(6) 2025.A bilateral mri was performed in december 2025 and showed a reduction, but persistence, of inflammation in the right shoulder.Pain has been getting worse, palexia medication has been required to treat it.The current health status of the patient is unknown.

• Brand Name: MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24404756
• Report Number: 3006524618-2026-00082
• Device Sequence Number: 8223790
• Product Code: MBI
• UDI-Device Identifier: 00885556614204
• UDI-Public: 885556614204
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K153669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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 Expiration Date: 09/01/2025
• Device Catalogue Number: 72290001
• Device Lot Number: 2099905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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 Age: 53 YR
• Patient Sex: Female