MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE VIP GLENOID PIN, NITINOL, 2.8MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DYNANITE VIP GLENOID PIN, NITINOL, 2.8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 28-jan-2026, a sales representative reported via (b)(4) that an ar-5400-400ns dynanite® vip¿ glenoid pin broke.This occurred during a reverse total shoulder arthroplasty procedure on (b)(6) 2026, the broken guide wire was noticed on postoperative x-ray, not intra-operative.Additional information was provided on 02-feb-2026 where the sales representative reported via (b)(4) that the patient had normal bone quality.The patient's bone was prepped using the ar-5400-400ns glenoid pin, ar-5400-s vip glenoid targeter set, ar-5410-01 vip¿ glenoid reamer, vip¿ augmented mgs reamer, ar-9596-1025f modular drill, and an ar-9582-25 modular post for augmented mgs baseplate 25 mm.The procedure was completed with standard procedural technique using rtsa, vip, and augmented mgs sets.There was no delay in the case.Additional information was provided on 03-feb-2026 where the sales representative reported via (b)(4) that an additional surgery took place on (b)(6) 2026 to remove the broken ar-5400-400ns dynanite vip glenoid pin.It was noted that the patient was doing fine.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on photographic evidence of an ar-5400-400ns, batch 15512964, that displays an out of place glenoid pin.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.Per dfu, instruments, dfu-0023-eo, revision 5, j.Warnings 2.After insertion of the instrument into the joint, do not apply additional flexion to the joint.A piece of a broken instrument can become lodged in soft tissue and/or disappear from the arthroscopic view of the surgical field resulting in possible fragments being retained in the patient.

• Brand Name: DYNANITE VIP GLENOID PIN, NITINOL, 2.8MM
• 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 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24345037
• Report Number: 1220246-2026-00621
• Device Sequence Number: 18652306
• Product Code: LXH
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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: DYNANITE VIP GLENOID PIN, NITINOL, 2.8MM
• Device Catalogue Number: AR-5400-400NS
• Device Lot Number: 15512964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• 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