MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-18 for TAP FOR 1.5MM CORTEX SCREWS 50MM 311.15 manufactured by Wrights Lane Synthes Usa Products Llc.
[114555844]
There is no patient involvement. It is unknown when device broke. Device is an instrument and is not implanted/explanted. Reporter email address is unavailable. Reporter is a synthes employee. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. A device history records review has been requested. 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.
Patient Sequence No: 1, Text Type: N, H10
[114555845]
It was reported that on an unknown date, a tap was found broken during inspection of the set by the loaners department. There was no patient involved. This report is for a tap for 1. 5mm cortex screws 50mm. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-52973 |
| MDR Report Key | 7699857 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-18 |
| Date of Report | 2018-06-27 |
| Date Mfgr Received | 2018-08-22 |
| Device Manufacturer Date | 2016-10-07 |
| Date Added to Maude | 2018-07-18 |
| 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 |
| Reporter Occupation | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAP FOR 1.5MM CORTEX SCREWS 50MM |
| Generic Name | DRIVER, WIRE, BONE DRILL MANUAL |
| Product Code | DZJ |
| Date Received | 2018-07-18 |
| Returned To Mfg | 2018-06-28 |
| Model Number | 311.15 |
| Catalog Number | 311.15 |
| Lot Number | L120834 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-18 |