MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203708
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an arthroscopic procedure, the healicoil anchor broke and the screw remained inside the patient.An additional bone hole was needed and a void was left.Surgery was completed with a competitor device instead.There was a surgical delay of more than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H11: 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 information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H11: h2: additional information in b7.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: part of the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The ultratape, ultrabraid, and anchor were not returned.The insertion device has no visible defect.A material assessment could not be performed due to the anchor not being returned for evaluation.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.A review of the material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include excessive force on the device, excessive torque on the device, off-axis insertion, or an inadvertent impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: 22110345
• Report Number: 1219602-2025-01273
• Device Sequence Number: 12820165
• Product Code: MAI
• UDI-Device Identifier: 00885554031423
• UDI-Public: 885554031423
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123393
• 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,Followup
• Report Date (Section B): 06/30/2025

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: 72203708
• Device Lot Number: 2132409
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 06/27/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/23/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2023
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 160 KG