MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203706
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a cuff repair surgery, the healicoil anchor immediately fractured while it was being screwed.The procedure was completed without surgical delay using a smith and nephew back up device.No further complications were reported.Patient current status is stable.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent 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 similar reported events.The instructions for use were 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 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 specification 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.A clinical review states intraoperative photos and photos of the device were provided for review and confirm the fracture.The broken anchor was retrieved from the patient.The clinical root cause of the reported events cannot be determined, and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The device ifu does caution that ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.¿ no further risk to the patient is anticipated as a result of the additional bone hole.Since no further harm is anticipated no further clinical assessment is warranted at this time.Factors that could have contributed to the reported event include an impact event inconsistent with normal use or excessive force.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H10: h2: additional information: b1, b2, b5: event description, h1.Corrected data: h6: health effect - clinical and impact code.
Event or Problem Description
It was reported that during a cuff repair surgery, the healicoil anchor immediately fractured while it was being screwed.All the broken pieces were retrieved from the patient using graspers.The procedure was completed without surgical delay using a smith and nephew back up device in an additional bone hole.No further complications were reported.Patient current status is stable.

• Brand Name: HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17471183
• Report Number: 1219602-2023-01418
• Device Sequence Number: 2531478
• Product Code: MAI
• UDI-Device Identifier: 00885554031416
• UDI-Public: 00885554031416
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151105
• 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): 12/19/2023

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: 07/06/2024
• Device Catalogue Number: 72203706
• Device Lot Number: 2074228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 08/25/2023; 12/13/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/04/2023; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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
• Patient Sex: Female