MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 9MM X 35MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204406
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the biosure screw broke while inserting it into tibial tunnel.The procedure was completed with a s+n back-up device.No delay was reported, and no other complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H2: additional information ¿h6: component code¿.
Additional Manufacturer Narrative
H2: additional information ¿h6: health effect - impact code¿.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 no way to determine if the device contributed to the reported event.A complaint history review concluded this was a repeat issue.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 review of risk management found that the anticipated risk level is no longer adequate.A review of the 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.It has not been reported whether the broken screw was retrieved from the patient¿s tibial tunnel.No clinically relevant supporting documentation was provided for review.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 inside of the patient, it is inside of the tibial tunnel, therefore, micro-motion/migration is unlikely.No further clinical/medical assessment is warranted at this time.The complaint was not confirmed.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 9MM X 35MM
• 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: 13261544
• Report Number: 1219602-2022-00071
• Device Sequence Number: 4818955
• Product Code: MAI
• UDI-Device Identifier: 00885554036824
• UDI-Public: 00885554036824
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2022

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: 08/19/2023
• Device Model Number: 72204406
• Device Catalogue Number: 72204406
• Device Lot Number: 50890623
• 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: 12/25/2021
• Supplement Date Received by Manufacturer: 02/21/2022; 02/21/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/22/2022; 02/22/2022
• 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 Sex: Unknown