MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 7MM X 20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204394
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during an acl reconstruction, a femoral perforation of 8.5 x 25mm was performed, graft and nitinol guide were passed and a screw biosure regenesorb 7mm x 20mm was passed, when it started to be screwed, a sound was heard and it was observed that it was broken.The procedure was completed with a surgical delay of less than 30 minutes using a smith and nephew back up device and a change in the surgical technique.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The device was returned with the distal end fractured away.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 specification 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 anchor material specification, 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 definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Other 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.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: additional information in b5.H11: corrected information in h6 (health effect - impact code).
Event or Problem Description
It was reported that during an acl reconstruction, a femoral perforation of 7mm with a 7mm x 25mm drill bit was performed.It was verified that there was no residue inside the tunnel in order to introduce the graft and then the screw.The graft and nitinol guide were passed and a screw biosure regenesorb 7mm x 20 mm was passed.When it started to be screwed, a sound was heard and it was observed that the screw was broken.The screw fragments were completely removed from the patient with grasper forceps.The procedure was completed with a surgical delay of less than 30 minutes using a smith and nephew back up device and a tap.No further complications were reported.

• Brand Name: SCREW BIOSURE REGENESORB 7MM X 20MM
• 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: 19906125
• Report Number: 1219602-2024-01651
• Device Sequence Number: 8731171
• Product Code: MAI
• UDI-Device Identifier: 00885554036701
• UDI-Public: 00885554036701
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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: 03/04/2025
• Device Catalogue Number: 72204394
• Device Lot Number: 51010050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 01/16/2025
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/09/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Male