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 2020-01-13 for RECLAIM TAPRD RMR INDEX 14-21 297650050 manufactured by Depuy Ireland - 9616671.
[189085954]
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: the 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.
Patient Sequence No: 1, Text Type: N, H10
[189085955]
It was reported that the reclaim tapered reamer index sizes 14-21 instrument tray is no longer usable. It is broken into 3 pieces. I was notified by email from a csr employee. This event did not occur during surgery so no patient was affected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-01647 |
| MDR Report Key | 9582731 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-11-14 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2018-09-21 |
| Date Added to Maude | 2020-01-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 | RECLAIM TAPRD RMR INDEX 14-21 |
| Generic Name | RECLAIM INSTRUMENTS : REAMERS |
| Product Code | FSM |
| Date Received | 2020-01-13 |
| Returned To Mfg | 2019-12-05 |
| Catalog Number | 297650050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-13 |