MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-19 for 11CM LONG ATTACH LONG-G1 manufactured by Depuy Synthes Products Llc.
[184441972]
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The actual device has been returned and is currently pending evaluation. Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184441973]
It was reported that during pre-surgery, it was discovered that the attachment device was overheating. There was no delay to the surgical procedure as an identical spare device was available for use. There was no patient involvement reported. 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 report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2020-00521 |
| MDR Report Key | 9856176 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2017-06-21 |
| Date Added to Maude | 2020-03-19 |
| 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 | 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 | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 11CM LONG ATTACH |
| Generic Name | MOTOR, DRILL, ELECTRIC |
| Product Code | HBC |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-18 |
| Model Number | LONG-G1 |
| Catalog Number | LONG-G1 |
| 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 | 2020-03-19 |