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 2019-04-19 for LONG SCALPEL HANDLE 03.010.491 manufactured by Wrights Lane Synthes Usa Products Llc.
[142490598]
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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
[142490599]
It was reported that on (b)(6) 2019, the metal tip of the long scalpel handle broke off during the period between completion of a trochanteric femoral nail advanced (tfna) surgical procedure and the washing/sterilization period at the hospital. It is unknown how this part was broken off, and the broken tip could not be found. The distal tip of the helical blade/screw coupling screw assembly was found slightly bent and did not advance over guide wire during surgery. There was no post-operative device malfunction and no adverse events reported. Procedure outcome is unknown. There was no patient consequence. Concomitant device reported: unknown guide wire (part # unknown, lot # unknown, quantity # 1). This report is for one (1) long scalpel handle. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-57571 |
| MDR Report Key | 8531512 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-19 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-05-23 |
| Device Manufacturer Date | 2018-03-14 |
| Date Added to Maude | 2019-04-19 |
| 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 | LONG SCALPEL HANDLE |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2019-04-19 |
| Returned To Mfg | 2019-04-09 |
| Model Number | 03.010.491 |
| Catalog Number | 03.010.491 |
| Lot Number | H437896 |
| 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 | 2019-04-19 |