MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 10MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an unknown procedure, the biosure screw broke while screwing inside the tibial tunnel.The procedure was completed with a non-significant delay using a back-up device.No patient complications were reported.
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 specification upon release for distribution.¿ a complaint history review found similar reported events.¿a review of the regenesorb compounded polymer, 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 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.¿it has not been reported whether the broken screw was retrieved from the patient.No clinically relevant supporting documentation was provided for review.Based on the limited information provided the root cause of the breakage could not be determined.It is unclear if the instructions for use were adhered to; however, it does caution that ¿excessive force should not be placed on the screw, bone, or delivery instruments.¿ if a portion of the biosure screw remains retained in the patient, it is made of a biocomposite material which is intended for implantation to allow for bone ingrowth.If the screw was retained it is unknown if the biosure screw will migrate and there is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.¿ 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: SCREW BIOSURE REGENESORB 10MM X 25MM
• 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: 12583655
• Report Number: 1219602-2021-02219
• Device Sequence Number: 1416361
• Product Code: MAI
• UDI-Device Identifier: 00885554036848
• UDI-Public: 00885554036848
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 11/19/2023
• Device Model Number: 72204408
• Device Catalogue Number: 72204408
• Device Lot Number: 50907102
• 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: 09/16/2021
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/15/2022
• Date Device Manufactured: 11/19/2020
• 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 Sex: Unknown