MAUDE Adverse Event Report: ARTHREX, INC. SUTRLASSO SD SFT,25°TIGHT LFT CRV,R; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTRLASSO SD SFT,25°TIGHT LFT CRV,R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
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
On 08/16/2024, it was reported by a sales representative via (b)(4) that an ar-5068-25tl suturelasso sd shaft broke during surgery (photo is attached) with no adverse effects on the patient.This was discovered during a procedure, with no reported patient harm.Additional information was requested.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-5068-25tl serial/batch number (b)(6) was received for investigation.Visual inspection noted that the tip of the device is broken off.Functional testing was not performed due to the damage to the device.The most likely cause is attributed to misuse due to prying/leveraging the device during use.

• Brand Name: SUTRLASSO SD SFT,25°TIGHT LFT 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: 20161000
• Report Number: 1220246-2024-07439
• Device Sequence Number: 15282128
• Product Code: LXH
• UDI-Device Identifier: 00888867035584
• UDI-Public: 00888867035584
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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,25°TIGHT LFT CRV,R
• Device Catalogue Number: AR-5068-25TL
• Device Lot Number: 0071714
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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