MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-20 for KINCISE REPL CAP HEAD ADAPTER FEMORAL 1013-00-901 manufactured by Depuy Synthes Products Llc.
[184433269]
Device was used for treatment, not diagnosis. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184433270]
It was reported that during set-up to an unspecified surgical procedure it was observed that the tip of the impactor device cracked and fell off. According to the report, the event occurred during a test fire of the cap head adapter device. It was reported that there was no delay in the procedure as a spare traditional head impactor device was available for use. It was reported that there was no loosening of the device. It was reported that no fragments of the device fell into the patient. There was patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was not reported. 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 | 1045834-2020-00531 |
| MDR Report Key | 9859880 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-08-03 |
| Date Added to Maude | 2020-03-20 |
| 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 | 3 |
| Brand Name | KINCISE REPL CAP HEAD ADAPTER FEMORAL |
| Generic Name | IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER |
| Product Code | GEY |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-17 |
| Catalog Number | 1013-00-901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-20 |