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 2018-07-23 for RASPING STRIKE PLATE 221701516 manufactured by Depuy Ireland 961610?.
[114678110]
(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
[114678111]
It was reported that the pinnacle tf gription rasping strike plate release button is broken and cannot be removed from the augment rasping handle. There was no surgical delay applicable to this case.
Patient Sequence No: 1, Text Type: D, B5
[118572251]
Product complaint #: (b)(4). Investigation summary: examination of the returned instrument confirmed the complaint. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will 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 | 1818910-2018-64948 |
| MDR Report Key | 7709829 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-23 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-06-27 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2012-05-16 |
| Date Added to Maude | 2018-07-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDIC 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 | 3 |
| Brand Name | RASPING STRIKE PLATE |
| Generic Name | GRIPTION TF INSTRUMENTS : IMPACTION INSTRUMENTS |
| Product Code | HTR |
| Date Received | 2018-07-23 |
| Returned To Mfg | 2018-07-11 |
| Catalog Number | 221701516 |
| Lot Number | SO2005149 |
| 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 IRELAND 961610? |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-23 |