MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ECLIPSE CAGE SCREW M, 35MM

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2020

Event Type  Injury  

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.

Event Description

It was reported that during an arthroplasty total shoulder using the eclipse, when using the central screw on the trunion, the screw locked up, which removed the central core of bone.They used the apex stem to completed the case.Additional information obtained 9/15/2020: when screwing the central screw in the two components locked causing the trunion to spin and the core of bone to come off in the central screw.The surgeon then chose to abort using the planned eclipse and instead implanted an apex stem to complete the procedure.

Manufacturer Narrative

Complaint not confirmed, the device was found to be undamaged.It fit the returned ar-9301-43cpc trunion without difficulty and was found to meet dimensional specifications.No abnormality was found on the device that may have contributed to the event.

• Brand Name: ECLIPSE CAGE SCREW M, 35MM
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10563104
• MDR Text Key: 207824580
• Report Number: 1220246-2020-02190
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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
• Device Operator: Health Professional
• Device Model Number: ECLIPSE CAGE SCREW M, 35MM
• Device Catalogue Number: AR-9301-02
• Device Lot Number: 19.02009
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other