MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203380
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a rotator cuff repair on a patient with a large full thickness tear, a healicoil sa pk 5.5mm w/3 ub-bl cbbl lt was de-threaded upon implantation.The standard implantation procedure was followed, 3.8 awl punched in up to the laser line.Then inserted the anchor into the pilot hole, upon twisting the anchor in, the anchor itself started to de-thread.All threads that came off the anchor were retrieved using a grasper and/or shaver to get remnants.The insertion site was cleared of all debris prior to insertion.The procedure was resumed, after a 5-10 minute delay, using an equivalent s+n back-up in the originally drilled bone hole.Patient is recovering well, normal expected postoperative recovery and the surgeon was ultimately satisfied with the surgical outcome.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).

• Brand Name: HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT
• 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: 24600332
• Report Number: 1219602-2026-00771
• Device Sequence Number: 15811107
• Product Code: MBI
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K113294
• 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): 09/11/2026

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: 72203380
• Device Lot Number: 2196320
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 03/14/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2025
• 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 Sex: Male
• Patient Weight: 205 LB