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 2018-04-27 for ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS 388.50 manufactured by Wrights Lane Synthes Usa Products Llc.
[106762421]
Reportedly there was no patient involvement. Device is an instrument and is not implanted/explanted. Part 388. 50, synthes lot 5214364, 5214365, supplier lot (b)(4): release to warehouse date: april 07, 2006. Supplier: (b)(4). No non-conformance reports (ncrs) were generated during production. Review of the device history record (dhr) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. A service and repair evaluation was completed: the customer reported the tube was loose and out of the track. The repair technician reported the tube was broken, and the spring and ratchet were worn. Worn out parts is the reason for repair. The cause of the issue is unknown. The following parts were replaced: tube, nut, ratchet, spring (set). The item was repaired and will be returned to the customer upon completion of the service and repair process. The evaluation was confirmed. 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
[106762422]
It was reported that a rod introduction pliers, for side-opening implants was not functioning properly. The set screw that secure the clip on the tube was not working correctly; it was loose and out of the track. This was identified during routine inspection; there was no patient or procedure involvement. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-51940 |
| MDR Report Key | 7468034 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-27 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-03-21 |
| Date Mfgr Received | 2018-04-26 |
| Device Manufacturer Date | 2006-04-07 |
| Date Added to Maude | 2018-04-27 |
| 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 | 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 | 2018-04-27 |
| Returned To Mfg | 2018-03-26 |
| Model Number | 388.50 |
| Catalog Number | 388.50 |
| Lot Number | A7PA13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-04-27 |