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 2019-05-23 for SIGMA HP UNI ANTERIOR CHISEL 202485000 manufactured by Depuy Orthopaedics, Inc. 1818910.
[145943924]
Product complaint # (b)(4). Examination of the returned device revealed breakage. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 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
[145943925]
Anterior chisel got stuck in the femoral finishing guide. Dr attempted to remove it after the case and the shaft of the chisel broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-94432 |
| MDR Report Key | 8636483 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-05-07 |
| Date Mfgr Received | 2019-06-11 |
| Device Manufacturer Date | 2013-09-19 |
| Date Added to Maude | 2019-05-23 |
| 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 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| 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 ANTERIOR CHISEL |
| Generic Name | KNEE INSTRUMENT : CUTTING INSTRUMENTS |
| Product Code | FZO |
| Date Received | 2019-05-23 |
| Returned To Mfg | 2019-05-16 |
| Catalog Number | 202485000 |
| Lot Number | PG236515 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-05-23 |