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

Model Number	SUTRLASSO SD SFT,45°RT CRV,R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the tip broke off and the fragment was not returned.No relevant features could be measured.No further abnormalities observed.The cause of the event is undetermined, however a likely cause is prying/leveraging the device during use.
Event or Problem Description
On 9/2/2021 it was reported by an arthrex employee via sems that an ar-5068-45r sutrlasso sd sft,45°rt crv,r broke off at the tip.This was discovered during a rcr on (b)(6) 2021.Surgeon was able to complete case by using a device from another manufacturer.No patient affected as the broken piece was retrieve from the patient.

• Brand Name: SUTRLASSO SD SFT,45°RT 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: 12953782
• Report Number: 1220246-2021-04059
• Device Sequence Number: 4390163
• Product Code: LXH
• UDI-Device Identifier: 00888867035621
• UDI-Public: 00888867035621
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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: 0071942
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown