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

Model Number	72204409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a knee surgery, at the time the inzquiotibial tendon, it was going to be attached to the tibia through the tunnel, the biosure regenesorb screw broke in half.The split half of the screw remained in the graft of the patient's knee without interfering.The procedure was completed with non-significant delay using the same device.No further complications were reported.
Event or Problem Description
It was reported that, during a knee surgery, at the time the inzquiotibial tendon, it was going to be attached to the tibia through the tunnel, the biosure regenesorb screw broke in half.The broken piece remained inside the patient and the function of placing the insert was fulfilled, so it was not necessary to place another screw.The procedure was completed with non-significant delay using the same device.No patient complications were reported.Patient's health condition is stable.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: additional information ¿b5: event description, h6: health effect - clinical 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.Per the complaint, the split screw remained the graft of the patient¿s knee without interfering.Since the screw is implantable, biocompatibility is not an issue.Additionally, the screw is secure inside of the graft in the patient's knee, therefore, micro-motion/migration is unlikely.According to the report, the procedure was completed in the same bone hole, with non-significant delay using the same device without patient complications.Since the patient's health condition is stable, 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 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: 12986807
• Report Number: 1219602-2021-02702
• Device Sequence Number: 5274403
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 05/13/2024
• Device Model Number: 72204409
• Device Catalogue Number: 72204409
• Device Lot Number: 50940644
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 02/22/2022
• Date Device Manufactured: 05/13/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Male