MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-24 for ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS 388.50 manufactured by Wrights Lane Synthes Usa Products Llc.
[121565838]
There is no patient involvement. It is unknown when device became damaged. Device is an instrument and is not implanted/explanted. 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 record 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
[121565839]
It was reported that during a routine inspection of instruments on (b)(6) 2018, it was noted that on the rod introduction pliers, its ratchet does not hold during loading according to a note on the device, and the pliers might be bent. There were no procedure and patient involvement. This report is for a rod introduction pliers for side-opening implants. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53923 |
| MDR Report Key | 7903326 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-24 |
| Date of Report | 2018-08-30 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-09-24 |
| 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 HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS |
| Generic Name | PLIERS, SURGICAL |
| Product Code | HTC |
| Date Received | 2018-09-24 |
| Returned To Mfg | 2018-09-04 |
| Model Number | 388.50 |
| Catalog Number | 388.50 |
| Lot Number | A7QA10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-09-24 |