MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS 388.509 manufactured by Wrights Lane Synthes Usa Products Llc.
[105569409]
Device used for treatment, not diagnosis. Patient information not available for reporting. 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. Device history records review not available to report at this time. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[105569410]
It was reported that one (1) table top rod cutter and bender had a lot of resistance, causing a rod to not pass in and out through the holes in the cutter, and one (1) rod introduction pliers for dual-opening implants for 6. 0 mm rods caused the scrub technicians a hard time loading an implant on it during a spinal fusion procedure on (b)(6) 2018, and subsequently, the handle on the pliers fell off at an unknown time. The scrub technicians were training a new recruit during a surgery when they loaded an unknown collar on the pliers and the pliers did not hold the collar as intended, giving the scrub technicians a hard time. Subsequently, the handle on the pliers was found to have fallen off after cleaning in the sterile processing department (spd) and it is unknown if the handle fell off during the surgery or during the cleaning process. Another set of pliers and cutter/bender were available at the time of the surgery and hence there was no surgical delay. The procedure was reported to have been completed successfully and without any complications. The patient condition was reported to have been stable. This complaint involves one (1) instruments. Concomitant devices reported: unknown collar (part# unknown, lot# unknown, quantity# 1); unknown 6. 0 mm rods (part# unknown, lot# unknown, quantity# unknown). This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-51604 |
| MDR Report Key | 7424085 |
| Date Received | 2018-04-11 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-03-14 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2004-08-26 |
| Date Added to Maude | 2018-04-11 |
| 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 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS |
| Generic Name | PLIERS,SURGICAL |
| Product Code | HTC |
| Date Received | 2018-04-11 |
| Returned To Mfg | 2018-03-27 |
| Model Number | 388.509 |
| Catalog Number | 388.509 |
| Lot Number | A7NA31 |
| 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 | 2018-04-11 |