MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for QUICKSET GRATER HANDLE ASSMB 244000520 manufactured by Depuy Orthopaedics Inc Us.
[102453738]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. No 510(k) number provided because this implant product code is sold internationally. It is sold in the us under a different product code.
Patient Sequence No: 1, Text Type: N, H10
[102453739]
It was reported that the connection point between the reamer and hudson adaptor broke off. The white reamer handle sleeve is cracked. No surgical delay. No pieces of instrumentation left in the patient.
Patient Sequence No: 1, Text Type: D, B5
[120165086]
Product complaint #: (b)(4). Investigation summary: the instrument associated with this report was not returned. 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, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-54994 |
| MDR Report Key | 7335380 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-02-20 |
| Date of Event | 2018-02-20 |
| Date Mfgr Received | 2018-09-10 |
| Date Added to Maude | 2018-03-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | QUICKSET GRATER HANDLE ASSMB |
| Generic Name | HIP INSTRUMENTS : HANDLES |
| Product Code | EKD |
| Date Received | 2018-03-13 |
| Catalog Number | 244000520 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-13 |