MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK BICEPS TENO, 7 X 10; BONE FIXATION SCREW/PLATE

Model Number	PEEK SWIVELOCK BICEPS TENO, 7 X 10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.
Event or Problem Description
On 08-aug-2022, it was reported by a sales rep via email that a ar-1662psl-710, peek swivelock biceps teno, 7 x 10 was cut by the end of the swivelock driver.This was discovered during use and a case was involved.No information was provided on how the procedure was completed.

• Brand Name: PEEK SWIVELOCK BICEPS TENO, 7 X 10
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: jared engle ; 8009337001
• MDR Report Key: 19237278
• Report Number: 1220246-2024-02740
• Device Sequence Number: 8106678
• Product Code: HWC
• UDI-Device Identifier: 00888867293151
• UDI-Public: 00888867293151
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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 Model Number: PEEK SWIVELOCK BICEPS TENO, 7 X 10
• Device Catalogue Number: AR-1662PSL-710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown