MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 7MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204395
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an acl procedure using the screw biosure regenesorb, at the time of placing the interference screw in the femur, it felt more resistant than usual, and it was noticed that the screw began to get entangled in the ligament tissue.When the fixation of the tibial screw was finished, it was evident that more than half of the graft got entangled in the screw.The screw had to be removed to prevent the graft from being damaged and to reposition the graft.The graft had to be pulled very hard, more than normal, and it even felt like the screw was trying to re-entangle.The procedure was finished with a delay greater than 30min using the same reported device.No further complications were reported.
Additional Manufacturer Narrative
H11: corrected data d3 and g1: manufacturing name, city and address.This report was inadvertently submitted under manufacturer report number "1643264", correct manufacturer report number is "1219602".
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.There was a relationship found between the device and the reported event.A complaint history review found no 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer provided image shows the complaint device, entangled in the graft, outside the patient.Since there were no other complications and it was reported the patient is in a stable condition, no further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause could not be established.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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 7MM 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: 12756105
• Report Number: 1643264-2021-02395
• Device Sequence Number: 4254859
• Product Code: MAI
• UDI-Device Identifier: 00885554036718
• UDI-Public: 00885554036718
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2023

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: 08/01/2023
• Device Model Number: 72204395
• Device Catalogue Number: 72204395
• Device Lot Number: 50890610
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 01/30/2023; 01/31/2023
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/31/2023; 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 62 KG