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 2018-10-26 for ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS 388.50 manufactured by Wrights Lane Synthes Usa Products Llc.
[125147153]
Part: 388. 50; synthes lot: 5214365; supplier lot: a7pa13; release to warehouse date: april 07, 2006; manufacturing site: synthes (b)(4); supplier: (b)(4). No nonconformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition. The customer reported the set screw was not long enough to stay on the track. The initial inspection of the device was completed on october 24, 2018. The repair technician reported that the collet was damaged. The cause of the issue is unknown. Service record router completed. Finalized service record will be archived. The device will be returned to the customer upon completion of the service and repair process. The evaluation was confirmed. During this investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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
[125147154]
It was reported that during a routine inspection of instruments on (b)(6) 2018, it was noted that it was noted that the following instruments were found to have device issues. On the first rod introduction pliers for side-opening implants, its set screw in the part that slides up and down the tube is not long enough to keep it in the track. On the second rod introduction pliers, its ratchet does not hold during loading according to a note on the device, and the pliers might be bent. There were no procedure and patient involvement. This report is for a rod introduction pliers for side-opening implants. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-54633 |
| MDR Report Key | 8008859 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-26 |
| Date of Report | 2018-08-30 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2006-04-07 |
| Date Added to Maude | 2018-10-26 |
| 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 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 | 2018-10-26 |
| Returned To Mfg | 2019-05-21 |
| Model Number | 388.50 |
| Catalog Number | 388.50 |
| Lot Number | 5214365 |
| 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 | 2018-10-26 |