MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 45 DEGREE CURVE RIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO, 45 DEGREE CURVE RIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
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
It was reported that during a labrum fixation the tip of the device broke inside the shaft.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 dw 04-oct-2024: further information was provided that the wire broke at the tip but remained inside the shaft.So not parts had to be retrieved out of the patient.
Event or Problem Description
Update (b)(6) 29-oct-2024.Initially it was reported that during a labrum fixation the tip of the device broke inside the shaft.Further information was provided that the wire broke at the tip but remained inside the shaft.So, no parts had to be retrieved out of the patient.However, during the receiving inspection by arthrex gmbh product surveillance it was found that the tip of the device is missing completely.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-4068-45r suturelasso¿ sd, 45° curve right serial/batch number (b)(6) was received for investigation.No functional testing was performed as it doesn't apply to this device due to the break.A visual evaluation revealed that the device's tip was broken off; a more in-depth evaluation found that the tip was not inside the shaft.The most likely cause(s) of the reported failure can be user error, misaligned insertion, or prying/leveraging the device during use.

• Brand Name: SUTURELASSO, 45 DEGREE CURVE RIGHT
• 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: 20410697
• Report Number: 1220246-2024-08053
• Device Sequence Number: 15714387
• Product Code: LXH
• UDI-Device Identifier: 00888867031494
• UDI-Public: (01)00888867031494(11)220101(17)261231(10)2005118359
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/21/2024

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: SUTURELASSO, 45 DEGREE CURVE RIGHT
• Device Catalogue Number: AR-4068-45R
• Device Lot Number: 2005118359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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