MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203983
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during rotator cuff repair, the healicoil de-threaded on insertion.Arthroscopic grasper were used to retrieve broken pieces.Procedure was completed after a non-significant delay (less or equal to 30min), with a back-up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: 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.An analysis of the customer provided image shows a anchor with broken threads.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the material found there are requirements for conformance and a certificate of material analysis is required it was determined the device did not contribute to the reported event.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.Per case details, the broken pieces were retrieved from the patient.One undated photo of the device was provided for review and confirms the reported.The customer feedback form notes that ¿no injury occurred to patient and another anchor was opened and successfully used.¿ since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.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 PK 5.5MM W/ UB2-CBR BLK UTP BL
• 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: 12771250
• Report Number: 1219602-2021-02437
• Device Sequence Number: 4217603
• Product Code: MBI
• UDI-Device Identifier: 00885554032109
• UDI-Public: 00885554032109
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2022

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: 03/12/2023
• Device Model Number: 72203983
• Device Catalogue Number: 72203983
• Device Lot Number: 50720214
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 07/30/2022
• Date Device Manufactured: 03/12/2018
• 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: Male