MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 9 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202272
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy, a biosure pk´s screw broke while it was being twist in.Surgery resumed after a non-significant delay, with a back-up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).H2: additional information in b5.H3, h6: part of the reported device was received for evaluation.There was no relationship found between the device and the reported event.A complaint history review found similar reported events.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 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 found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A visual inspection of the returned device found that the open packaging was returned with no device.A review of the customer provided image finds the box for the complaint device.Based on the condition of the product material found during visual inspection, additional material testing is not required.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 it is unknown if the biosure screw will migrate and there is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.The complaint was not confirmed, and the root cause could not be determined.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.
Event or Problem Description
It was reported that during an arthroscopy, where a 8mm drill was used to prepare the insertion site, a biosure pk´s screw broke while it was being twist in.Surgery resumed after a non-significant delay, with a back-up device used in the originally drilled bone hole, therefore no voids were left in the patient.Patient´s health status is good.No further complications were reported.

• Brand Name: BIOSURE PK 9 X 25MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, 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: 15700752
• Report Number: 1219602-2022-01646
• Device Sequence Number: 18211959
• Product Code: MBI
• UDI-Device Identifier: 03596010621634
• UDI-Public: 03596010621634
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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 Model Number: 72202272
• Device Catalogue Number: 72202272
• Device Lot Number: 50977328
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Male