MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-16 for SOCKET WRENCH FOR VEPTR NUT 03.641.004 manufactured by Wrights Lane Synthes Usa Products Llc.
[184644686]
Occupation: initial reporter is a synthes employee the previous service event for part number 03. 641. 004 with lot number(s) h130932-22 has been reviewed. The customer called in a service request for this item on (b)(6) 2020 for failed calibration. The item was previously returned for service on (b)(6) 2018 due to failed calibration. The previous service condition of failed calibration is relevant to the current complained issue of failed calibration. The manufacture date of this item is october 19, 2016. The service history review is confirmed. A service and repair evaluation was completed: during evaluation at service and repair, the repair technician reported the device failed high in calibration. Torque test high is the reason for repair. The item is not repairable per the inspection sheet. The cause of the issue is unknown. The item will be forwarded to customer quality. The evaluation was confirmed. A product investigation was completed: the socket wrench was received with no visual defects. A functional test was performed by service and repair and the repair technician reported the device failed high in calibration. The complaint was able to be replicated therefore the complaint is confirmed. The relevant drawing was reviewed. There is no indication that a design or manufacturing issue contributed to the complaint. While no definitive root cause could be determined it is possible that the device encountered unintended forces. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. No new malfunctions were observed during the course of this investigation. 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
[184644687]
It was reported on (b)(6) 2020, during testing at service and repair, the technician found out that the socket wrench had failed in calibration. There was no patient involvement. This report is for a socket wrench. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01287 |
| MDR Report Key | 9834974 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2016-10-19 |
| Date Added to Maude | 2020-03-16 |
| 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 | SOCKET WRENCH FOR VEPTR NUT |
| Generic Name | WRENCH |
| Product Code | HXC |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-02-17 |
| Model Number | 03.641.004 |
| Catalog Number | 03.641.004 |
| Lot Number | H130932-22 |
| 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 | 2020-03-16 |