MAUDE Adverse Event Report: ARTHREX, INC. 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via phone that qty.2 of an ar-1926bcsp pushlock had an issue during a rotator cuff repair procedure on (b)(6) 2023.During the cuff mend, when the surgeon malleted the first pushlock, the self-punching eyelet broke off the metal inserter inside the patient.All broken fragments were removed.Another ar-1926bcsp pushlock with the same lot number was opened, and the same malfunction occurred, the eyelet also broke off the metal inserter inside the patient, and all fragments were removed.The first complaint device was discarded, and the second device is available for return.The surgeon switched to an ar-2324 bcct swivelock anchor, lot number 14981365, to complete the procedure successfully with no impact or harm to the patient.
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
Additional info: h6.Complaint is confirmed.Visual evaluation identified that the device returned is missing the eyelet and suture threader.However, the broken pieces were not returned for investigation.The most common cause of this event is the excessive force applied during use.The cause remains undetermined.

• Brand Name: 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 16564885
• Report Number: 1220246-2023-06437
• Device Sequence Number: 17513053
• Product Code: MAI
• UDI-Device Identifier: 00888867395213
• UDI-Public: 00888867395213
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K221099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: 07/31/2025
• Device Model Number: 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING
• Device Catalogue Number: AR-1926BCSP
• Device Lot Number: 14035360
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown