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

Model Number	45 DEG CURVE LEFT, QUICKPASS LASSO
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/11/2017
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 cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a shoulder stabilisation surgery the tip of the device broke inside the patient.All the broken fragments are retrieved and nothing will remain inside the patient.The surgeon changed the surgical technique from arthroscopic to open.This was necessary to retrieve the broken fragment.
Additional Manufacturer Narrative
Complaint confirmed.The evaluation confirmed the tip broke at the weld joint and the shaft was bent.Both breakage and bending may occur as a result of leveraging the device against hard bone or another instrument.The device met all material specifications as received.

• Brand Name: 45 DEG CURVE LEFT, QUICKPASS LASSO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7751161
• Report Number: 1220246-2018-00592
• Device Sequence Number: 19252000
• Product Code: LXH
• UDI-Device Identifier: 00888867038929
• UDI-Public: 00888867038929
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: No Information
• Device Model Number: 45 DEG CURVE LEFT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-45L
• Device Lot Number: UNK1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other