MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation was confirmed based on the customer's attached picture case-(b)(4) _incoming picture 1.Jpg, which revealed the damage to the device.Evaluation of the customer's attached picture of the ar-5035tc-10 cannulated delta tapered biocomposite interference screw, 10 mm x 35 mm, batch 15162964: it was observed that the bio screw was broken off at the distal end; the screw tip geometry is missing due to the breakage.The method of bone preparation employed during the procedure and the bone quality encountered were not provided.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause(s) of the reported failure can be user error, such as improper bone preparation, misaligned insertion, or prying/leveraging the device during insertion.Direction for use.Dfu-0111-eor2_fmt_en.G.Precautions.5.Bio cortical and delta tapered interference screw only: insert the screwdriver into the screw to a fully seated position.Failure to engage the screw completely may result in damage to the implant.6.Bio-absorbable interference screw only: it is important to completely seat the screwdriver to prevent potential stripping of the hex and/or screw fracture during insertion or removal.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the screw broke during insertion.All fragments were retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.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.

• Brand Name: BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM
• 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: 20744543
• Report Number: 1220246-2024-08583
• Device Sequence Number: 20904846
• Product Code: MAI
• UDI-Device Identifier: 00888867035515
• UDI-Public: (01)00888867035515(11)231103(17)271031(10)15162964
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• 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
• Report Date (Section B): 11/21/2024

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 Model Number: BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM
• Device Catalogue Number: AR-5035TC-10
• Device Lot Number: 15162964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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