MAUDE Adverse Event Report: ARTHREX, INC. HIP LABRAL SCORPION; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HIP LABRAL SCORPION
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2019
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.Per the customer the device will not be returned.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 it was not possible to open the jaw of the scorpion correctly during a hip-ask-labrum surgery, out of the joint it was possible to open the scorpion.It was not possible to finish the surgery successfully so a second surgery will be necessary.The date for the second surgery is not known at the moment.Update 01-apr-19: according to the customer, the scorpion works fine outside the patient.As soon as it was in the patient the jaw did not open any more.The surgeon confirmed it was his error.

• Brand Name: HIP LABRAL SCORPION
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8500364
• Report Number: 1220246-2019-01023
• Device Sequence Number: 2816974
• Product Code: LXH
• UDI-Device Identifier: 00888867184312
• UDI-Public: 00888867184312
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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 Model Number: HIP LABRAL SCORPION
• Device Catalogue Number: AR-16991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other