MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW FT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/08/2018
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 requested/is expected but has 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 arthroscopic procedure, the suture anchor, ar-1928sf-45, broke upon insertion.The case was completed by using another suture anchor.Further information requested.

• Brand Name: SUTR ANCH,CRKSCRW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8208823
• Report Number: 1220246-2019-00820
• Device Sequence Number: 14151207
• Product Code: HWC
• UDI-Device Identifier: 00888867023741
• UDI-Public: 00888867023741
• Combination Product (Y/N): N
• PMA/510(K) Number: K061863
• 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): 01/02/2019

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 Expiration Date: 02/28/2023
• Device Model Number: SUTR ANCH,CRKSCRW FT
• Device Catalogue Number: AR-1928SF-45
• Device Lot Number: 10198195
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other