MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-04 for ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS 388.509 manufactured by Wrights Lane Synthes Usa Products Llc.
[135421962]
Occupation: reporter is synthes sales consultant. A review of the device history records has been requested. The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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
[135421963]
It was reported that on an unknown date, the two (2) rod introduction pliers for dual-opening would not engage to hold the unknown collars when trying to load the instrument before starting a case. The collar kept falling off the persuader after trying to load it. The two technicians tried hard multiple times with multiple collars and were not successful in loading any collars to either of the persuaders. There was no patient involvement since it was discovered before starting the case. Concomitant device reported: unknown collars (part#: unknown, lot#: unknown, quantity#: unknown). This report is for one (1) rod introduction pliers for dual-opening impl. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-56312 |
| MDR Report Key | 8303139 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-04 |
| Date of Report | 2019-01-18 |
| Date Mfgr Received | 2019-03-07 |
| Device Manufacturer Date | 2018-09-14 |
| Date Added to Maude | 2019-02-04 |
| 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 | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS |
| Generic Name | PLIERS, SURGICAL |
| Product Code | HTC |
| Date Received | 2019-02-04 |
| Returned To Mfg | 2019-01-29 |
| Model Number | 388.509 |
| Catalog Number | 388.509 |
| Lot Number | H387389 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-04 |