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

Model Number	72203380
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Perforation (2001); Rupture (2208)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a rotator cuff repair with allopath procedure, a healicoil anchor went in without difficulty as the bone quality was soft, after bringing in allopath and looked back at the anchor, it seemed as it had burst, meaning that the device came out slightly and split.Surgery resumed after a delay greater than 30 minutes, after the broken anchor was removed using graspers, with a back-up device in a new bone hole; leaving a void in the patient.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.An analysis of the customer provided images found two arthroscopic images showing a split anchor, and an image of the broken anchor in a plastic container.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive force on the device, off-axis insertion, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.Corrected data: h6: health effect - clinical and impact code.

• 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: 16364215
• Report Number: 1219602-2023-00167
• Device Sequence Number: 12465967
• Product Code: MBI
• UDI-Device Identifier: 00885554026313
• UDI-Public: 00885554026313
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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 Model Number: 72203380
• Device Catalogue Number: 72203380
• Device Lot Number: 2086935
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 08/10/2023
• Date Device Manufactured: 02/12/2022
• 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
• Patient Sex: Unknown