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 2020-03-19 for TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING 321.133 manufactured by Wrights Lane Synthes Usa Products Llc.
[188666699]
Investigation summary service and repair evaluation: the customer reported the item failed in calibration. The repair technician reported the item failed high. The cause of the issue is failed low. The item was sent to the vendor for re-calibration on 4-mar-2020. The device will be returned to the customer upon completion of the service and repair process. Attached service record router completed through operation 21. Finalized service record will be archived in tungsten document management system. The evaluation was confirmed. The device was deemed serviceable and will be 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 history lot part # 321. 133. Synthes lot # 4730338. Supplier lot # 536873b04. Release to warehouse date: mar 01, 2004. Supplier: beere precision. No ncr's were generated during production. Device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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
[188666700]
It was reported on february 21, 2020, during testing at service and repair, the torque limiting handle has failed in calibration. There was no patient involvement. This complaint involves one (1) device. This is 1 of 1 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01373 |
| MDR Report Key | 9856008 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2020-03-19 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| 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 | TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING |
| Generic Name | SCREWDRIVERS |
| Product Code | HXX |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 321.133 |
| Catalog Number | 321.133 |
| Lot Number | 4730338 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-19 |