MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 10MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that acl surgery, the biosure regenesorb screw was being fixed on the tibial area, it was noticed that it became loose and a click sound was heard.The screw was removed and it was noticed that there were broken edges on the screw.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.
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.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 polymer specifications 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.A clinical review states that all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.There is a likely root cause of inadequately prepared bone hole based on the information provided , as it was reported that the tibial area ¿was dilated 7mm to generate way to the screw 10 * 30¿; therefore, unable to rule out a user technique/variance/non-adherence to the ifu as likely contributing factors to the reported osteoconductive biocomposite screw breakage.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device was returned with several broken threads and damage to the proximal collar, there is biological debris on the returned device.Based on the condition of the product material found during visual inspection, additional material testing is not required.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.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 storage requirements are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A clinical review states that there is a likely root cause of inadequately prepared bone hole based on the information provided, as it was reported that the tibial area ¿was dilated 7mm to generate way to the screw 10 * 30¿; therefore, we are unable to rule out a user technique/variance/non-adherence to the ifu as likely contributing factors to the reported osteoconductive biocomposite screw breakage.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, excessive torque on the device, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.H11: corrected information in h6 (investigation findings & conclusions).

• Brand Name: SCREW BIOSURE REGENESORB 10MM X 30MM
• 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: 19757115
• Report Number: 1219602-2024-01540
• Device Sequence Number: 15704532
• Product Code: MAI
• UDI-Device Identifier: 00885554036855
• UDI-Public: 00885554036855
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2026
• Device Catalogue Number: 72204409
• Device Lot Number: 51152199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 02/13/2025
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/22/2024; 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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
• Patient Sex: Male