MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-FASTAK; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,BIO-FASTAK
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/17/2019
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.The remaining portion of the device was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
During a fixation of the labrum capsule the anchor broke off.One part of the anchor (with the structure) remain on the driver, the other part remain inside the patient.The surgeon tried to remove it but it was not possible to remove the fragment.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 25-apr: the unretrieved fragment is located at the glenoid.The part of the anchor attached to the driver was discarded.The patient did not suffer any consequential damage or impairment of any kind.

• Brand Name: SUTR ANCH,BIO-FASTAK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8611468
• Report Number: 1220246-2019-01096
• Device Sequence Number: 2220806
• Product Code: HWC
• UDI-Device Identifier: 00888867010321
• UDI-Public: 00888867010321
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: 04/30/2020
• Device Model Number: SUTR ANCH,BIO-FASTAK
• Device Catalogue Number: AR-1324BF
• Device Lot Number: 10211190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other