MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-27 for 1.5 MM MULTISCREW/LAG SCREW CADDY 80-2391 manufactured by Acumed Llc.
[184513819]
The lid (80-1820) and caddy (80-2391) interface was physically examined and is stuck as described in the description. The lid could not be removed by hand during this evaluation. The metal on metal contact between the sliding lid and the caddy base can cause wear over time due to the friction during the sliding on and off motion. The anodization of the components does help this motion, however it appears that the anodization has worn where the two components interface, which can be a factor in the lid getting stuck. Additional mdrs associated with this event: 3025141-2020-000034: lid.
Patient Sequence No: 1, Text Type: N, H10
[184513820]
During surgical treatment of a routine finger fracture in an elderly patient, the surgeon requested a screw but the lid could not be removed from the caddy. This prevented the surgeon from finishing as he planned and surgery was delayed at least 15 minutes, trying to open the screw caddy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3025141-2020-00035 |
| MDR Report Key | 9763634 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2015-02-15 |
| Date Added to Maude | 2020-02-27 |
| 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 | MS. MICKI ANDERSON |
| Manufacturer Street | 5885 NE CORNELIUS PASS ROAD |
| Manufacturer City | HILLSBORO OR 97124 |
| Manufacturer Country | US |
| Manufacturer Postal | 97124 |
| Manufacturer G1 | ACUMED LLC |
| Manufacturer Street | 5885 NE CORNELIUS PASS ROAD |
| Manufacturer City | HILLSBORO OR 97124 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.5 MM MULTISCREW/LAG SCREW CADDY |
| Generic Name | TRAY, SURGICAL, INSTRUMENT: CADDY |
| Product Code | FSM |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-17 |
| Model Number | 80-2391 |
| Catalog Number | 80-2391 |
| Lot Number | 338338 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACUMED LLC |
| Manufacturer Address | 5885 NE CORNELIUS PASS ROAD HILLSBORO OR 97124 US 97124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |