MAUDE Adverse Event Report: ARTHREX, INC. CENTRAL SCREW, NL, UNI REV, 6.5X20MM; PROSTHESIS, SHOULDER, CEMENTED

Model Number	CENTRAL SCREW, NL, UNI REV, 6.5X20MM
Medical Device Problem Codes	Positioning Failure (1158); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an inverse prosthesis surgery the screws ar-9145-30 (lot: 22.02176) and ar-9165-20nl (lot: 15019430) could not be tightened when the base plate ar-9120-02 (lot: 22.03081) and the glenosphere ar-9504m-04 (lot: 22.02710) were implanted.As a result, the glenoid did not hold and had to be removed again.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique.A second surgery was required on the (b)(6) 2023.Update avoe 07-dec-2023, it was confirmed that the second surgery was required due to the failure of the screws, which didn`t lock like normally.
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
Additional information: d9, g3, h3, h6 the complaint is confirmed.One unpackaged ar-9165-20nl central screw, non-locking, univers revers¿ 6.5 x 20 mm, batch 15019430, was received for evaluation.The screw was received attached to the baseplate that is attached to the glenosphere.Visual evaluation of the screw: it was noted that there were minor nicks on the thread.The screw is attached to the baseplate in the central screw hole -no functional test or measurement was performed due to the screw arriving attached to the base plate for evaluation.It is concluded that the most likely cause of the failure is a user error in failing to apply the correct surgical technique for the device.Per universal glenoid convertible baseplate surgical technique.Step 10.Thread the peripheral screw drill guide into the superior bushing and advance the 2.5 mm drill to the desired trajectory and depth, taking note of the depth marks on the drill guide and drill.Insert and fully seat the screw until completely flush with baseplate surface.Insert the peripheral screw drill guide in the inferior bushing and drill to the desired depth using the 2.5 mm drill.Insert and fully seat the screw until completely flush with baseplate surface.Surgical pearl: leave the 2.5 mm drill in place while removing the peripheral screw drill guide.This helps the bushing stay in the trajectory of the drilled hole, which will facilitate peripheral screw locking thread engagement.

• Brand Name: CENTRAL SCREW, NL, UNI REV, 6.5X20MM
• 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: 18429260
• Report Number: 1220246-2024-00009
• Device Sequence Number: 20769434
• Product Code: KWS
• UDI-Device Identifier: 00888867136670
• UDI-Public: 00888867136670
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130129
• 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): 11/26/2024

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: CENTRAL SCREW, NL, UNI REV, 6.5X20MM
• Device Catalogue Number: AR-9165-20NL
• Device Lot Number: 15019430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown