MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-10 for ECLIPSE CAGE SCREW S, 30MM AR-9301-01 manufactured by Arthrex, Inc..
[186007709]
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.
Patient Sequence No: 1, Text Type: N, H10
[186007710]
It was reported during an eclipse total shoulder procedure, the surgeon sawed the humeral head off, put cap on the humerus and completed the glenoid without issue. When the surgeon came back to complete the humerus, the bone quality was very poor and the ar-9301-01 (lot: 18. 01100) cage screw would not hold. Upon pulling out the cage screw it was noted that the screw was full of bone. The surgeon then switched to a longer cage screw (ar-9301-02 / lot: 18. 01106) to get a deeper bite, but it pulled out as well. The rep stated at this point the surgeon was very upset, and decided to remove all implanted product and switch to an mgs reverse total shoulder. The rep reported no additional incisions were needed, just a different implant system was used to complete the procedure without further issue. The following products were first implanted, and then immediately explanted; ar-9301-01 / lot: 18. 01100 - eclipse small cage screw, ar-9301-02 / lot: 18. 01106 - eclipse medium cage screw, ar-9301-41cpc / lot: 18. 01145 - eclipse trunnion size 41, ar-9121-01 / lot: 170139713 - glenoid inlay small, ar-9165-25nl / lot: 10221985 - central non-locking screw, ar-9145-36 / lot: 18. 00586 - peripheral locking screw, ar-9145-24 / lot: 18. 00585 - peripheral locking screw, ar-9165-25nl / lot: 10204555 - central non-locking screw (the rep stated screw was dropped on the floor and had to be wasted), ar-9120-01pc / lot: 17. 01676 - revers glenoid. All removed products were discarded and will not be returning for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01757 |
| MDR Report Key | 9810633 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-02-13 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECLIPSE CAGE SCREW S, 30MM |
| Generic Name | TOTAL SHOULDER ARTHROPLASTY SYSTEM |
| Product Code | QHQ |
| Date Received | 2020-03-10 |
| Model Number | ECLIPSE CAGE SCREW S, 30MM |
| Catalog Number | AR-9301-01 |
| Lot Number | 18.01100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-10 |