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 2019-05-20 for SIGMA HP UNI FB KEEL OSTEOTOME 202447111 manufactured by Depuy Orthopaedics, Inc. 1818910.
[145612304]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[145612305]
It was reported that the back screw piece was broke off that holds tibia gauge in handle. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-94086 |
| MDR Report Key | 8625716 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-06-10 |
| Device Manufacturer Date | 2014-10-13 |
| Date Added to Maude | 2019-05-20 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 19380XXXX |
| Manufacturer Country | US |
| Manufacturer Postal | 19380XXXX |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| 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 | 2019-05-20 |
| Returned To Mfg | 2019-05-15 |
| Catalog Number | 202447111 |
| Lot Number | GM4214002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-20 |