MAUDE Adverse Event Report: ARTHREX, INC. GLENOID RMR SFT W/GLOVE PROTECTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GLENOID RMR SFT W/GLOVE PROTECTOR
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed.Visual evaluation did not showed any damaged.The twist attachment was not returned.During device functioning testing, the device was able to be attached to a known good reamer.
Event or Problem Description
It was reported that during a eclipse vaultlock surgery it was found that the attachment of the shaft was twisted and it did not fit into the reamer attachment.Therefore the surgeon had to use the jacob's chuck to finish the surgery successfully.There was no harm for patient, operator or third party reported.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: GLENOID RMR SFT W/GLOVE PROTECTOR
• 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: 19285127
• Report Number: 1220246-2024-03070
• Device Sequence Number: 12842232
• Product Code: LXH
• UDI-Device Identifier: 00888867058965
• UDI-Public: 00888867058965
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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: GLENOID RMR SFT W/GLOVE PROTECTOR
• Device Catalogue Number: AR-9211
• Device Lot Number: 149809490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 05/10/2024
• 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