MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 8MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72204401

Device Problem Break (1069)

Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Date 04/05/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during an acl reconstruction surgery, while installing a regenesorb screw using a biosure screwdriver, the screw broke.One part of the screw remained in the patient¿s bone and was not extracted; it was left in the bone.The second part of the screw remained attached to the screwdriver.The backup screw was implanted near the broken screw.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found half of the broken screw next to its box with its identification information.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.The instructions for use were 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 material 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.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include excessive force, off-axis insertion, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

H11: corrected information in b1, b2 and h1.

• Brand Name: SCREW BIOSURE REGENESORB 8MM X 30MM
• Type of Device: 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: 19187949
• MDR Text Key: 341173306
• Report Number: 1219602-2024-00882
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554036770
• UDI-Public: 00885554036770
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K142948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 72204401
• Device Lot Number: 51163007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/31/2024; 05/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention