MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-02-19 for ATTUNE PATELLA COMPRESSION RNG 254501042 manufactured by Depuy Ireland 9616671.
[137419441]
(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
[137419442]
Nurses reported attune patella clamps are not holding together well and asked for replacements. Was surgery delayed due to the reported event? No, was procedure successfully completed? Yes, were fragments generated? No, if yes, were they removed easily without additional intervention? Unknown, patient status/ outcome / consequences: no, was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, (b)(6). Device property of: none, device in possession of: none, (b)(6). Device property of: none, device in possession of: none. By checking this box i certify that all information that are known/available has been disclosed. If any new information will be made available, the additional information will be submitted through cst. True.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-84949 |
| MDR Report Key | 8349622 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-01-07 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-02-19 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 19380XXXX |
| Manufacturer Country | US |
| Manufacturer Postal | 19380XXXX |
| Manufacturer Phone | 6107428552 |
| 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 | ATTUNE PATELLA COMPRESSION RNG |
| Generic Name | ATTUNE INSTRUMENTS : PATELLA HANDLE/CLAMPS |
| Product Code | HWN |
| Date Received | 2019-02-19 |
| 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 | 1. Required No Informationntervention | 2019-02-19 |