MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/19/2020
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 a after an initial hip labrum stabilization on (b)(6) 2020 it was found during the aftercare that the patient has developed lysis.The surgeon has further reported that the reported event has been seen with other patients as well but was not able to provide any further information regarding these events.

• Brand Name: SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10786048
• Report Number: 1220246-2020-02313
• Device Sequence Number: 11497558
• Product Code: MAI
• UDI-Device Identifier: 00888867195844
• UDI-Public: 00888867195844
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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 Model Number: SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM
• Device Catalogue Number: AR-2923BCH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other