MAUDE Adverse Event Report: ARTHREX, INC. SUTRLASSO SD SFT,45°LFT CRV,R; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTRLASSO SD SFT,45°LFT CRV,R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a facility nurse via medwatch mailed in letter that an ar-5068-45l suturelasso sd shaft broke into two pieces inside the patient.This was discovered during an arthroscopic labrum repair of right shoulder on (b)(6) 2022.At this time, it is unknown if the broken fragments were retrieved from inside the patient.Lot number is also unknown, no further information has been provided.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: SUTRLASSO SD SFT,45°LFT CRV,R
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14075096
• Report Number: 1220246-2022-04718
• Device Sequence Number: 4807822
• Product Code: LXH
• UDI-Device Identifier: 00888867035614
• UDI-Public: 00888867035614
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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°LFT CRV,R
• Device Catalogue Number: AR-5068-45L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown