MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-14 for ATTUNE PATELLA COMPRESSION RNG 2545-01-042 254501042 manufactured by Depuy Ireland - 9616671.
[189087071]
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.
Patient Sequence No: 1, Text Type: N, H10
[189087072]
During an end of year inspection a number of instruments were noted to have damage making compromising their sterility. A list was provided noting shims to have hairline cracks near the bearing surfaces articulation surfaces with pitting damage and rubber patella clamps with tears and rubber degrading. Items will be sent for replacement when or re-opens and will follow up with more details. No patient or surgical involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-01826 |
| MDR Report Key | 9588603 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-28 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2020-03-25 |
| Date Added to Maude | 2020-01-14 |
| 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 | 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 | ATTUNE PATELLA COMPRESSION RNG |
| Generic Name | ATTUNE INSTRUMENTS : PATELLA HANDLE/CLAMPS |
| Product Code | HWN |
| Date Received | 2020-01-14 |
| Model Number | 2545-01-042 |
| Catalog Number | 254501042 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-14 |