MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,FASTAK,SM BONE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH,FASTAK,SM BONE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/31/2020
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 when the anchor was implanted, the driver broke leaving a "metallic shine", in addition to the anchor itself, in the patient's wrist.Due to this event, the surgery time was extended.Currently, no revision surgery is scheduled.Should the fragment disturb the patient, a revision surgery will be scheduled.No further information has been made available.Update 07-sep-2020: "metallic shine" was meant as metallic fragment.

• Brand Name: SUTR ANCH,FASTAK,SM BONE
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10546681
• Report Number: 1220246-2020-02176
• Device Sequence Number: 3033165
• Product Code: MBI
• UDI-Device Identifier: 00888867285002
• UDI-Public: 00888867285002
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K971723
• 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): 09/17/2020

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 Expiration Date: 04/30/2025
• Device Model Number: SUTR ANCH,FASTAK,SM BONE
• Device Catalogue Number: AR-1322-752SF-1
• Device Lot Number: 10999239
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other