MAUDE Adverse Event Report: ARTHREX, INC. VIP¿ GLENOID REAMER, PILOT; PROSTHESIS, SHOULDER, CEMENTED

Model Number	VIP¿ GLENOID REAMER, PILOT
Medical Device Problem Codes	Dull, Blunt (2407); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via (b)(4) that an ar-5400-02 glenoid targeter handle and an ar-5410-01 vip glenoid reamer pilot were worn.The case was completed by swapping out the devices.This was discovered during an unspecified procedure, with no adverse effects on the patient.
Additional Manufacturer Narrative
Additional information.Complaint is confirmed.Upon visual inspection, it was noted that the edges of peripheral collar of the returned fresa glenoidea vip¿, piloto, had damaged between the slots and had strong abrasion marks around it.The edges around the reamer shaft had chipped.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to interference with the mating instrument.

• Brand Name: VIP¿ GLENOID REAMER, PILOT
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: emily shafer ; 8009337001
• MDR Report Key: 18110764
• Report Number: 1220246-2023-08665
• Device Sequence Number: 7891527
• Product Code: KWS
• UDI-Device Identifier: 00888867392250
• UDI-Public: 00888867392250
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K222007
• 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): 11/22/2024

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: VIP¿ GLENOID REAMER, PILOT
• Device Catalogue Number: AR-5410-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 11/22/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown