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 2019-11-13 for SIGMA HP UNI FB KEEL OSTEOTOME 202447111 manufactured by Depuy Orthopaedics Inc Us.
| Report Number | 1818910-2019-115937 |
| MDR Report Key | 9316626 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-13 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-10-18 |
| Date Mfgr Received | 2019-10-18 |
| Device Manufacturer Date | 2008-08-15 |
| Date Added to Maude | 2019-11-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIGMA HP UNI FB KEEL OSTEOTOME |
| Generic Name | KNEE INSTRUMENT : CUTTING INSTRUMENTS |
| Product Code | HWM |
| Date Received | 2019-11-13 |
| Returned To Mfg | 2019-10-23 |
| Catalog Number | 202447111 |
| Lot Number | GM0808 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-13 |