MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-22 for ME1000 CUP-ADAPTER-PINNACLE STRAIGHT 1011-01-101 manufactured by Depuy Synthes Products Llc.
[133844025]
The actual device has been returned and is currently pending evaluation. Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
[133844026]
It was reported that during service and repair/pretest, it was observed that the clover leaf fitting guide was detached from the adapter device and the threaded portion was broken off inside where it attaches. It was further determined that the device failed pre-test for visual assessment. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2019-52682 |
| MDR Report Key | 8266872 |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-09 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 2017-05-04 |
| Date Added to Maude | 2019-01-22 |
| 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 | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | TECHTRONIC INDUSTRIES MEDICAL |
| Manufacturer Street | 1428 PEARMAN DAIRY RD |
| Manufacturer City | ANDERSON SC 29625 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ME1000 CUP-ADAPTER-PINNACLE STRAIGHT |
| Generic Name | IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER |
| Product Code | GET |
| Date Received | 2019-01-22 |
| Returned To Mfg | 2019-01-08 |
| Catalog Number | 1011-01-101 |
| Lot Number | N/A |
| 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 SYNTHES PRODUCTS LLC |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-22 |