MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a biceps tendon surgery the anchor did not separate from the driver.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-1922bcm suture anchor, biocomposite pushlock® sp 4.5 x 28 mm serial/batch number (b)(6) was received for evaluation.Upon visual inspection, it was noted that the device arrived with the eyelet and the bio on the shaft.Damage, such as nicks, was observed on the bio/screw, and dents, similar to nicks, were noted on the eyelet.Functional testing was performed moving the inner shaft to check for resistance/damaged.No problem was found.The most likely causes of the reported failure is a user error improper surgical technique.Directions for use.Dfu-0087-eor3_fmt_en.Corkscrew®, pushlock®, and swivelock® suture anchors.G.Precautions: 2.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.

• Brand Name: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• 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: 21363799
• Report Number: 1220246-2025-00395
• Device Sequence Number: 8451529
• Product Code: MAI
• UDI-Device Identifier: 00888867022898
• UDI-Public: (01)00888867022898(11)240603(17)280531(10)15257198
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• Device Catalogue Number: AR-1922BCM
• Device Lot Number: 15257198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2024
• 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