MAUDE Adverse Event Report: ARTHREX, INC. PERC INSERT KIT FOR 3.0MM S-TAK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PERC INSERT KIT FOR 3.0MM S-TAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2026, it was reported by arthrex legal via email that a patient underwent a procedure to correct a glenohumeral instability on (b)(6) 2022.The patient complained of neck and shoulder pain for a period following the surgery.A follow-up x ray in 2023 revealed a broken metal fragment in the shoulder space.The origin device of the metal fragment is unknown.There was a revision procedure in (b)(6) 2024 to remove the fragment.The products used in the original procedure were: ar-1934pi-30 perc insert kit, (3) three ar-1938bc suture anchor, (3) three ar-3636 fibertak anchors, and (2) two ar-6570f flexible cannulas.

• Brand Name: PERC INSERT KIT FOR 3.0MM S-TAK
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 24637949
• Report Number: 1220246-2026-01510
• Device Sequence Number: 15913318
• Product Code: LXH
• UDI-Device Identifier: 00888867024151
• UDI-Public: (01)00888867024151(11)220822(17)270731(10)14993607
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PERC INSERT KIT FOR 3.0MM S-TAK
• Device Catalogue Number: AR-1934PI-30
• Device Lot Number: 14993607
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown