MAUDE Adverse Event Report: ARTHREX, INC. 45 DEG CURVE RIGHT, FASTPASS LASSO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	45 DEG CURVE RIGHT, FASTPASS LASSO
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the lasso tip broke off inside the patient.The surgeon performed an additional open approach and was able to retrieve the part out of the patient and proceeded the open repair of bony bankart and stabilization.No harm for patient, operator or third party was reported.The surgery was finished successfully.Additional information obtained 30-mar-2020: further information were received that the surgeon had changed the procedure to an open procedure to retrieve the missing parts out of the patient.No additional surgery was performed.

• Brand Name: 45 DEG CURVE RIGHT, FASTPASS LASSO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9935780
• Report Number: 1220246-2020-01789
• Device Sequence Number: 16332309
• Product Code: LXH
• UDI-Device Identifier: 00888867038936
• UDI-Public: 00888867038936
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 45 DEG CURVE RIGHT, FASTPASS LASSO
• Device Catalogue Number: AR-6068-45R
• Device Lot Number: 921295940
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other