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	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an unknown procedure, the healicoil threads were broken when screwing into the bone.The procedure was successfully completed with a surgical delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: h2: additional information: b1, b2, b5.Corrected data: h1 and h6: health effect - clinical and impact code.
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the healicoil threads were broken when screwing into the bone.All the broken pieces were removed from patient using arthroscopic grasper.The procedure was successfully completed with a surgical delay of less than 30 minutes using a smith and nephew back up device in an additionally drilled bone hole.No further complications were reported.Patient was discharged from the hospital.
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not 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 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 specifications found that the raw material strength requirements and storage requirements are specified and each lot must be accompanied by a material certificate of analysis.A clinical review states that a procedural variance could not be ruled out as a likely contributory factor of the reported adverse event.No further risk to the patient is anticipated as a result of the additional bone hole.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18539461
• Report Number: 1219602-2024-00132
• Device Sequence Number: 17738158
• Product Code: MBI
• UDI-Device Identifier: 00885554026313
• UDI-Public: 00885554026313
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K152566
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2024

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: 72203380
• Device Lot Number: 2109744
• 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: 12/28/2023
• Supplement Date Received by Manufacturer: 01/22/2024; 03/18/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 01/30/2024; 03/19/2024
• Date Device Manufactured: 02/22/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown