MAUDE Adverse Event Report: ARTHREX, INC. CNULA.SCRW,STRL PT THD 3.75X38MM; SCREW, FIXATION, BONE

Model Number	CNULA.SCRW,STRL PT THD 3.75X38MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-7000-38s (no batch number provided) was received for investigation.Visual inspection identified breakage at the distal end of the returned ar-7000-38s.It was determined that approximately 1.4955" of the screw was returned.The screw diameter was assessed and was found to meet design specifications.The method used to prepare the joint during the procedure, as well as the bone quality encountered, was not provided.The cause remains undetermined, although a probable cause can be attributed to improper bone preparation.
Event or Problem Description
It was reported that during gleno-ac-joint surgery, the screw was delaminated during the procedure.The broken off piece has been retrieved from the patient.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a different device, 10304992.It was not necessary to switch the surgical technique or do a second surgery.No further information received.Update, 21-sep-2021.Received further information that the screw was broken.

• Brand Name: CNULA.SCRW,STRL PT THD 3.75X38MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12615226
• Report Number: 1220246-2021-03770
• Device Sequence Number: 4985958
• Product Code: HWC
• UDI-Device Identifier: 00888867041127
• UDI-Public: 00888867041127
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K143614
• 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
• Report Date (Section B): 10/12/2021

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: 11/30/2024
• Device Model Number: CNULA.SCRW,STRL PT THD 3.75X38MM
• Device Catalogue Number: AR-7000-38S
• Device Lot Number: 10532702
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1