MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID PRIMARY REAMER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERSAL GLENOID PRIMARY REAMER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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
It was reported that during a glenoid change surgery a ring at the tip of the drill bit broke off.The fragment stayed attached to the drill.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Corrected info: additional manufacturer narrative.The reported event was confirmed as one unpackaged ar-9126rp, universal glenoid primary reamer, batch number 04511912, was received for investigation and upon visual inspection, it was observed that the depth stop is broken off (see evaluation pictures 1 + 3).The most likely cause for the reported failure can be attributed to improper use / device handling.Functional testing was not performed due to the damage of the device.The broken off depth stop was returned for evaluation.Further, the cutting edges are heavily damaged (see evaluation pictures 4 + 5).Also, the device shows signs of metal surface oxidation and faded laser marks (see evaluation picture 2).

• Brand Name: UNIVERSAL GLENOID PRIMARY REAMER
• 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: 24884259
• Report Number: 1220246-2026-02222
• Device Sequence Number: 13224573
• Product Code: LXH
• UDI-Device Identifier: 00888867057623
• UDI-Public: (01)00888867057623(11)190326(10)04511912
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: UNIVERSAL GLENOID PRIMARY REAMER
• Device Catalogue Number: AR-9126RP
• Device Lot Number: 04511912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Distributor Facility Aware Date: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown