MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-07 for RALLY ALL IN ONE CEMENT GUN 71271610 manufactured by Smith & Nephew, Inc..
[141312907]
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Patient Sequence No: 1, Text Type: N, H10
[141312908]
It was reported that during surgery, the rally cement gun was not strong enough to push 70gm of cement out. The gun broke due to the force exerted to get the cement out. Delay of less than 30 minutes and no backup available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-01402 |
| MDR Report Key | 8489933 |
| Date Received | 2019-04-07 |
| Date of Report | 2019-09-23 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-06-20 |
| Date Added to Maude | 2019-04-07 |
| 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 | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| 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 | 0 |
| Brand Name | RALLY ALL IN ONE CEMENT GUN |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2019-04-07 |
| Catalog Number | 71271610 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 | 2019-04-07 |