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 2018-10-09 for ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS 388.50 manufactured by Wrights Lane Synthes Usa Products Llc.
[123403684]
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. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[123403685]
It was reported that during a routine inspection on (b)(6) 2018, the issue tabs on a rod introduction pliers for side-opening implants were found to be splayed. The sleeve is also stuck on the tube and will not move. It was also noted that the ratchet on another rod introduction pliers for side-opening implants falls off and will not stay on the instrument. There was no patient involvement. This report is for one (1) rod introduction pliers for side-opening implants. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-54281 |
| MDR Report Key | 7950145 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-09 |
| Date of Report | 2018-09-21 |
| Date Mfgr Received | 2018-11-19 |
| Device Manufacturer Date | 2016-10-26 |
| Date Added to Maude | 2018-10-09 |
| 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 | 2018-10-09 |
| Returned To Mfg | 2018-09-27 |
| Model Number | 388.50 |
| Catalog Number | 388.50 |
| Lot Number | T134820 |
| 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 | 2018-10-09 |