MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-09 for CALCAR MILL MEDIUM 2001-48-000 200148000 manufactured by Depuy Orthopaedics, Inc. 1818910.
[176691459]
Product complaint #: (b)(4). Investigation summary: the examination of the returned instrument confirmed the complaint. The root cause is attributed to heavy usage. 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
[189066496]
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
[189066497]
Upon inspection of the reamer, the surgeon determined the reamer was dull.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-01170 |
| MDR Report Key | 9568542 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2020-01-09 |
| 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 | CALCAR MILL MEDIUM |
| Generic Name | HIP INSTRUMENTS : CUTTING INSTRUMENTS |
| Product Code | LYS |
| Date Received | 2020-01-09 |
| Returned To Mfg | 2019-12-26 |
| Model Number | 2001-48-000 |
| Catalog Number | 200148000 |
| Lot Number | HW88039 |
| 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 ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-09 |