MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRG IMP SYS W/BIO-COMP SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SPEEDBRG IMP SYS W/BIO-COMP SWVLK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
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 surgery the blue handle of the punch from the speedbridge¿ implant system ar-2600sbs-4 (lot: 14325652) got loose from the shaft and could be rotated without the shaft.The bone quality was good.Per complaint reporter there was no harm for patient, operator or third party.No further information was provided.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is not confirmed.-visual inspection noted that the component ar-1927pbsuit has some abrasion marks on the shaft.-functional testing was performed and the handle was not able to move in any direction.The most likely cause is attributed to design issue updating the drawing in eco-34751.

• Brand Name: SPEEDBRG IMP SYS W/BIO-COMP SWVLK
• 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: 23438551
• Report Number: 1220246-2025-04935
• Device Sequence Number: 4758597
• Product Code: MAI
• UDI-Device Identifier: 00888867027312
• UDI-Public: (01)00888867027312(11)211013(17)250930(10)14325652
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 09/30/2025
• Device Model Number: SPEEDBRG IMP SYS W/BIO-COMP SWVLK
• Device Catalogue Number: AR-2600SBS-4
• Device Lot Number: 14325652
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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