MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-08 for PFC STEM TRIAL EXTRACT 865226 manufactured by Depuy Orthopaedics Inc Us.
[94394517]
(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
[94394518]
It was reported that the stem trial extract were broken during a cadaver lab training on (b)(6) 2017. Tip of handle broken off.
Patient Sequence No: 1, Text Type: D, B5
[104062428]
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
[104608313]
Product complaint # pc-(b)(4). Investigation summary: examination of the returned device confirmed the reported event. Depuy synthes considers the investigation closed. 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
| Report Number | 1818910-2017-51026 |
| MDR Report Key | 7099432 |
| Date Received | 2017-12-08 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2018-04-04 |
| Date Added to Maude | 2017-12-08 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PFC STEM TRIAL EXTRACT |
| Generic Name | TRIAL EXTRACTOR |
| Product Code | HBW |
| Date Received | 2017-12-08 |
| Returned To Mfg | 2017-11-21 |
| Catalog Number | 865226 |
| Lot Number | TX6104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-08 |