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 2018-05-15 for ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS 388.50 manufactured by Wrights Lane Synthes Usa Products Llc.
[108376828]
Patient information not available for reporting. Device is an instrument and is not implanted/explanted. Dhr review was completed. Part number: 388. 50. Synthes lot number: 6946399. Supplier lot number: n/a. Release to warehouse date: 24-jul-2012. Expiration date: n/a. Manufactured by (b)(4). Ncr was generated during production for 3 of 13 parts missing certs. Paperwork was reworked and all passed inspection. This non-conformance is not relevant to the complaint condition since it is not related to complaint condition of the device not holding while the instrument was depressed, a crack in the spring of the device, and rod bender with bend radius adjustment device was not working properly and might be missing a spring. Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition. Service & repair conducted an investigation of the returned device. Service & repair evaluation: the customer reported the pliers were not holding, and the spring was cracked. The repair technician reported the spring was broken, and the pliers were too tight. Leaf/spring broken is the reason for repair. The cause of the issue is unknown. The following parts were replaced: ratchet, spring (set). The item was repaired per the inspection sheet, passed synthes final inspection on 10-may-2018 and will be returned to the customer upon completion of the service and repair process. Attached service record router completed through operation 30. Finalized service record will be archived in docusphere document management system. The evaluation was confirmed. The device was deemed serviceable and returned to the customer, no design or manufacturing issues were identified therefore 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
[108376829]
It was reported that during an unknown spinal surgery on (b)(6) 2018, it was noted the rod introduction pliers for side-opening implants was not holding while the instrument was depressed. There was also a crack noted in the spring of the device. During the same procedure it was noted that the rod bender with bend radius adjustment was missing the spring, which prevented the device from tightening. Both devices were set aside and other similar devices were readily available and were used to complete the surgery successfully with no delay and no patient harm. The service and repair evaluation revealed the spring on the rod introduction pliers was broken and the pliers were too tight. This report is for one (1) rod introduction pliers for side-opening implants. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-52194 |
| MDR Report Key | 7516703 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-15 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-05-10 |
| Device Manufacturer Date | 2012-07-24 |
| Date Added to Maude | 2018-05-15 |
| 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 | 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 | 2018-05-15 |
| Returned To Mfg | 2018-04-16 |
| Model Number | 388.50 |
| Catalog Number | 388.50 |
| Lot Number | 6946399 |
| 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 | 2018-05-15 |