MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW L, 40MM; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ECLIPSE CAGE SCREW L, 40MM
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/09/2020
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
It was reported that the pegged glenoid got loose after seven years.A revision surgery will be necessary.Update swit 23-dec-2020: initial surgery took place on (b)(6) 2013.Surgery report indication: patient hat pain in the right shoulder for about three to four years with only some limited movement.The apron grip in particular is increasingly limited.The examinations including an arthro mri from (b)(6) 2012 revealed a pronounced omarthrosis with a slap lesion at a high level.The humeral head is progressively subluxating dorsally.The indication for shoulder arthroplasty is clear.Revision surgery took place on (b)(6) 2020.
Additional Manufacturer Narrative
Complaint not confirmed, no abnormality was observed on the device that may have contributed to the event.

• Brand Name: ECLIPSE CAGE SCREW L, 40MM
• Common Device Name: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11841617
• Report Number: 1220246-2021-03097
• Device Sequence Number: 3747711
• Product Code: QHQ
• UDI-Device Identifier: 00888867059948
• UDI-Public: 00888867059948
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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 Expiration Date: 11/30/2015
• Device Model Number: ECLIPSE CAGE SCREW L, 40MM
• Device Catalogue Number: AR-9301-03
• Device Lot Number: 1009701
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other