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 Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder surgery the surgeon couldn't unscrew the handle, and the eyelet wouldn't come off; the surgeon forced it to come off and ended up tearing everything apart.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.***update 04-sep-2026 a user report was provided with further information.It was further reported that the anchor holder did not release the anchor after impaction.Failure to pose.The practitioner used another provider's anchor.There was a light patient harm, as one additional anchor hole had to be drilled.After impaction of the anchor, it was impossible to remove the anchor holder with its handle.The surgeon needed to tear off the assembly to remove everything.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50896187
• Report Number: 1220246-2026-04888
• Device Sequence Number: 12219720
• Product Code: MAI
• UDI-Device Identifier: 00888867022904
• UDI-Public: (01)00888867022904(11)260317(17)300228(10)15590780
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082810
• 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): 09/25/2026

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 Model Number: BIOCOMPOSITE PUSHLOCK SP 4.5MM X 28MM
• Device Catalogue Number: AR-1922BCM-1
• Device Lot Number: 15590780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2026
• 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 Sex: Unknown