MAUDE Adverse Event Report: ARTHREX, INC. CRESCENT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-6068C
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.The most likely cause of this type of event is the use of excessive force and/or prying/leveraging with the tip fully exposed on the device during use.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Per customer device will not be returned.
Event or Problem Description
It was reported that during a labral repair, the tip of the crescent, quickpass lasso broke-off in the soft tissue of the shoulder joint.Per the surgeon the broken piece was secure so it was not removed.The patient was released from surgery center per facility protocol.Patient was a (b)(6) female, dob (b)(6).
Additional Manufacturer Narrative
Patient demographics (date of birth, weight) were requested but not provided.This is a follow-up submission due to device evaluation.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.Complaint confirmed.The device met all material specifications as received.The evaluation revealed broken tip on the returned device due to stress fracture.This type of event is typically caused by prying/leveraging against hard bone or another instrument.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a labral repair, the tip of the crescent, quickpass lasso broke-off in the soft tissue of the shoulder joint.Per the surgeon the broken piece was secure so it was not removed.The patient was released from surgery center per facility protocol.Patient was a (b)(6) female, dob (b)(6) 2016.

• Brand Name: CRESCENT, QUICKPASS LASSO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5911982
• Report Number: 1220246-2016-00347
• Device Sequence Number: 19139969
• Product Code: LXH
• UDI-Device Identifier: 00888867038981
• UDI-Public: 00888867038981
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2016

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 Catalogue Number: AR-6068C
• Device Lot Number: 529659767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2016
• Supplement Report FDA Received Date: 09/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR