MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO SD SHAFT, 90 DEG STRAIGHT, R; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTURELASSO SD SHAFT, 90 DEG STRAIGHT, R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during rot surgery, the tip of the suturelasso did break off while inserting into the rotator cuff.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.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.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-5068-90, batch 007164903 was received for investigation.Visual inspection identified that the tip of the suturelasso tip was returned broken from the main assembly at the weld with the shaft.Surface damage was present across the tip, although inspection with digital micrometer id: 224 identified that the tip width met design specifications.The cause remains undetermined, although a probable cause can be attributed to prying/leveraging the suturelasso tip during use.

• Brand Name: SUTURELASSO SD SHAFT, 90 DEG STRAIGHT, R
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12576523
• Report Number: 1220246-2021-03741
• Device Sequence Number: 4522613
• Product Code: LXH
• UDI-Device Identifier: 00888867035638
• UDI-Public: 00888867035638
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: SUTURELASSO SD SHAFT, 90 DEG STRAIGHT, R
• Device Catalogue Number: AR-5068-90
• Device Lot Number: 007164903
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1