MAUDE Adverse Event Report: ARTHREX, INC. SUTRLASSO SD SFT,45°RT CRV,R; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTRLASSO SD SFT,45°RT CRV,R
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 08th jan 2026, it was reported by a distributor via email that sutrlasso sd sft,45°rt crv, r ar-5068-45r lot 0072332 was bent and subsequently broke during the procedure pm (b)(6) 2026.The surgery was completed without complications using a new (ar-5068-xx) with no fragments retained in the patient¿s body and no harm reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SUTRLASSO SD SFT,45°RT CRV,R
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 24160279
• Report Number: 1220246-2026-00288
• Device Sequence Number: 18420036
• Product Code: LXH
• UDI-Device Identifier: 00888867035621
• UDI-Public: (01)00888867035621(11)230911(10)0072332
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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 Model Number: SUTRLASSO SD SFT,45°RT CRV,R
• Device Catalogue Number: AR-5068-45R
• Device Lot Number: 0072332
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown