MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCHBIO-COMP S-TAK KNOTLESS; SCREW, FIXATION, BONE

Model Number	SUTR ANCHBIO-COMP S-TAK KNOTLESS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/27/2017
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 disposition is unknown and 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.
Event or Problem Description
It was reported that the ar-1938bc, biocomposite suturetak knotless anchor broke upon insertion.Additional information has been requested.Additional information obtained: the procedure taking place was a labrum repair.The surgical coordinator stated that the only information made available regarding the complaint was that the device broke in and out upon insertion.The case was completed with a replacement ar-1938bc of the same lot number (lot: 10071743).The facility confirmed that the device will not be returning for evaluation due to the unknown disposition of the device.The facility reporter states they have no confirmation on the status of whether there is a retained device portion left in the patient.

• Brand Name: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7693316
• Report Number: 1220246-2018-00551
• Device Sequence Number: 16410368
• Product Code: HWC
• UDI-Device Identifier: 00888867097186
• UDI-Public: 00888867097186
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Device Catalogue Number: AR-1938BC
• Device Lot Number: 10071743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/17/2018
• 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: 46 YR