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

Model Number	SUTR ANCH,CRKSCRW FT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the little pin in the center of the screen holding the fiber wire came off, resulting in the fiber wire pulling out.There was no harm for patient, user or third-party.The surgery was finished successfully.Update (b)(6) 2021: a piece broke off inside the patient.It was recovered from the patient.
Additional Manufacturer Narrative
Complaint not confirmed.Visual inspection under magnification confirmed that the crosspin was missing from the suture anchor, but it cannot be confirmed that this pin broke during use.The cause of why the pin is missing could not be determined.

• 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: 11912001
• Report Number: 1220246-2021-03178
• Device Sequence Number: 3426512
• Product Code: HWC
• UDI-Device Identifier: 00888867023741
• UDI-Public: 00888867023741
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: SUTR ANCH,CRKSCRW FT
• Device Catalogue Number: AR-1928SF-45
• Device Lot Number: 10460671
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 09/15/2021
• Patient Sequence Number: 1