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

Model Number	UNIVERSAL GLENOID CORING REAMER, SMALL
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/21/2024, it was reported by a sales representative via (b)(4) that an ar-9127-01 arthrex universal glenoid coring reamer was missing the white-centered knob and was discovered during the case.The case was completed by unthreading one from the medial reamer and putting it on the small reamer to finish the case and nothing broke inside the patient.This was discovered during a reverse total shoulder procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 5/29/2024: there was no case delay.
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
Complaint allegation is confirmed.One unpackaged, ar-9127-01 /batch 04511802, coring reamer, was received for evaluation.Upon visual evaluation it was noted that the white cap (alignment tip) is missing.Functional testing could not be performed due to the damage of the device.The most likely cause is attributed to wear and tear due to repeated use of the device.The manufacturing date is january 2018.

• Brand Name: UNIVERSAL GLENOID CORING REAMER, SMALL
• 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: 19565867
• Report Number: 1220246-2024-06054
• Device Sequence Number: 6954704
• Product Code: LXH
• UDI-Device Identifier: 00888867057630
• UDI-Public: 00888867057630
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/19/2024

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: UNIVERSAL GLENOID CORING REAMER, SMALL
• Device Catalogue Number: AR-9127-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown