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 2020-01-24 for ATTUNE PATELLA DRILL CLAMP 254501041 manufactured by Depuy Ireland - 9616671.
[178260676]
(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
[178260677]
Broken and worn patella clamp for attune, noticed by cssd. No event occurred during surgery. No further information is available apart from what is supplied in this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-02816 |
| MDR Report Key | 9627681 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2014-04-14 |
| Date Added to Maude | 2020-01-24 |
| 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 DRILL CLAMP |
| Generic Name | ATTUNE INSTRUMENTS : PATELLA HANDLE/CLAMPS |
| Product Code | HXD |
| Date Received | 2020-01-24 |
| Catalog Number | 254501041 |
| Lot Number | NW146262 |
| 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 | 2020-01-24 |