MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 8 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202267
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	01/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, four months after a left knee anterior cruciate ligament reconstruction on (b)(6) 2023 using biosure pk 8 x 25mm screws, on the post-operative review, it was concluded that the patient recovered well, with magnetic resonance imaging suggesting that the ligament was healing well.However, the patient did not follow the doctor's advice and sprained his left knee again when playing basketball on his own.The patient was hospitalized again on (b)(6) 2024 for arthroscopic surgery.It is unknown the outcome of the patient.
Additional Manufacturer Narrative
H6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.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 no 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 clinical review states that the ifu addresses that the patient must be willing/able to restrict activities during the healing period.The patient reportedly did not follow the doctor¿s advice and resumed basketball sometime after the 4-month checkup which resulted in a re-injury/additional procedure.Based on the information provided, a device malperformance is not supported.The current patient status is unknown as the requested clinical documentation was reportedly unavailable.Based on the limited information provided we are unable to conclude on factors known to contribute to the alleged report.As of this investigation, the need for corrective action is not indicated.

• Brand Name: BIOSURE PK 8 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: 19337654
• Report Number: 1219602-2024-01059
• Device Sequence Number: 15239593
• Product Code: MBI
• UDI-Device Identifier: 03596010621627
• UDI-Public: 03596010621627
• 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): 07/01/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 72202267
• Device Lot Number: 51019052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 07/01/2024
• Date Device Manufactured: 04/04/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Sex: Male