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	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff surgery the anchor broke on the distal part.There was no harm for patient, operator or third party reported.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.
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.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1928sf-45-1 driver was received for investigation.Visual inspection identified breakage along the fourth-fifth distal-most threads.No fragments were received, and no other abnormalities were noted.The method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.A probable cause can be attributed to improper bone preparation.

• Brand Name: SUTR ANCH,CRKSCRW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12737747
• Report Number: 1220246-2021-03862
• Device Sequence Number: 4081140
• Product Code: HWC
• UDI-Device Identifier: 00888867284951
• UDI-Public: 00888867284951
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 03/31/2026
• Device Model Number: SUTR ANCH,CRKSCRW FT
• Device Catalogue Number: AR-1928SF-45-1
• Device Lot Number: 13055489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown