MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-22 for ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS 388.509 manufactured by Synthes Monument.
[87861488]
Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(6). The investigation could not be completed; no conclusion could be drawn, as no product was received. Dhr review for part# 388. 509 lot# a7pa03 synthes lot # 5164062. Release to warehouse date: 30jan2006, supplier: (b)(4), no ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. 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
[87861489]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a lumbar discectomy and fusion on (b)(6) 2017 using the uss (universal spinal system), the rod introduction pliers device was being used to seat the uss collar over the screw and tighten onto the rod. This device has a collet that slides up and down and the collet is gently tapped in order to bring down a "sleeve cap" (uss collar) into position. As the surgeon impacted it, this collet (sliding portion) broke off. The part was manually retrieved and surgery was completed with a second similar device. There was no surgical delay, and no reported harm to the patient. This complaint involves one device. This report is for one (1) rod introduction pliers. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2017-10969 |
| MDR Report Key | 6888649 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-02 |
| Date of Event | 2017-09-02 |
| Date Mfgr Received | 2017-10-26 |
| Device Manufacturer Date | 2006-01-30 |
| Date Added to Maude | 2017-09-22 |
| 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 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| 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 | 2017-09-22 |
| Returned To Mfg | 2017-09-22 |
| Model Number | 388.509 |
| Catalog Number | 388.509 |
| Lot Number | A7PA03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-22 |