MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SITE P-LCK 2.9X 15.5; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SITE P-LCK 2.9X 15.5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the implant slipped off the bone.It was further reported that the dedicated drill was used.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-1923bc-1 serial/batch, 14913159, was received for investigation.Functional testing with the driver was not performed due to the damaged to the de screw, the visual evaluation revealed that the screw had broken off, there was a crack, and the eyelet was inside.The most likely causes are improper bone prep, misaligned insertion, prying, and/or leveraging the device.

• Brand Name: BIO-COMP SITE P-LCK 2.9X 15.5
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19232887
• Report Number: 1220246-2024-02725
• Device Sequence Number: 5919569
• Product Code: MAI
• UDI-Device Identifier: 00888867023024
• UDI-Public: 00888867023024
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: BIO-COMP SITE P-LCK 2.9X 15.5
• Device Catalogue Number: AR-1923BC-1
• Device Lot Number: 14913159
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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
• Patient Sex: Unknown