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 2018-10-15 for ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS 388.50 manufactured by Wrights Lane Synthes Usa Products Llc.
[123806306]
There was no known reported patient involvement associated with the complained event. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[123806307]
It was reported that on an unknown date, a rod introduction plier for side-opening implant tube was rotated and the sleeve (holds the collar implant) that slides up and down the "tube" got jammed on the tube during a routine inspection of consignment instrument sets. The set screw that keeps the sleeve in an open track on the tube was too short and does not go into the track far enough. There was no patient and procedure involvement. This report is for one (1) rod introduction pliers for side-opening implants. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-54387 |
| MDR Report Key | 7967044 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-15 |
| Date of Report | 2018-10-01 |
| Date Mfgr Received | 2018-11-28 |
| Device Manufacturer Date | 1999-01-28 |
| Date Added to Maude | 2018-10-15 |
| 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 | MR. 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 | 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 SIDE-OPENING IMPLANTS |
| Generic Name | PLIERS, SURGICAL |
| Product Code | HTC |
| Date Received | 2018-10-15 |
| Returned To Mfg | 2018-10-23 |
| Model Number | 388.50 |
| Catalog Number | 388.50 |
| Lot Number | 3914478 |
| 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 | 2018-10-15 |