MAUDE Adverse Event Report: ARTHREX, INC. Ø7X 20MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø7X 20MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
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 rotator cuff repair surgery a piece of the screw broke while insertion.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully and the screw remained inside the patient.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 was confirmed.One unpackaged ar-4020c-07 batch 15392109 was received for evaluation.Visual inspection revealed that the screw¿s thread profile was severely damaged.Only a portion of the screw was returned for evaluation.Additionally, it was noted that the major diameter of the screw head had shrunk due to a bend.Functional testing cannot be performed as the device was damaged.The most likely cause of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The screw's major diameter was measured according to drawing c18872 at revision 2, component c18872-02 at revision 2: 0.276+.009/-.005 inches.The result was 0.256 inches.Due to the damage to the screw, the measurement is out of specification.

• Brand Name: Ø7X 20MM BC IF SCRW, VENTED
• 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: 23095096
• Report Number: 1220246-2025-03953
• Device Sequence Number: 18334463
• Product Code: MAI
• UDI-Device Identifier: 00888867276956
• UDI-Public: (01)00888867276956(11)250219(17)281231(10)15392109
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K202535
• 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): 11/05/2025

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: Ø7X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-07
• Device Lot Number: 15392109
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown