MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-21 for REAMER QUICK CONNECT 71355094 manufactured by Smith & Nephew, Inc..
[177239073]
It was reported that when setting up for the case when connecting the reamer quick-connect handle to the distal reamer it was difficult pulling back the shaft of the quick connect handle. Nurse was directed to try the second handle and found the same issue. He was then told to gently tap the handle on the edge of the tray to help loosen the shaft and large shards of dried blood fell from both handles into the tray of reamers. That tray was deemed unsterile and as there are no alternatives to the reamer quick connect handles the surgeon had no other option but to use a competitor system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00346 |
| MDR Report Key | 9610398 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-01-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REAMER QUICK CONNECT |
| Generic Name | PRSTHSIS, HIP, SM-CONSTRAINED, UNCMNTD, MTL/PLYMR, NON-POROUS |
| Product Code | MEH |
| Date Received | 2020-01-21 |
| Model Number | 71355094 |
| Catalog Number | 71355094 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-21 |