MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for REAMING ROD PUSH ROD WITH BALL HANDLE 03.010.093 manufactured by Wrights Lane Synthes Usa Products Llc.
[186753523]
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[186753524]
Device report from canada reports an event as follows: it was reported that on february 24, 2020 that the rod pushers do not fit properly through the reaming rod because one is bent and the other is too big. A replacement rod pusher was used to complete the procedure successfully with a surgical delay of five (5) minutes. Concomitant device: unknown reaming rod (part # unknown, lot # unknown, quantity # 1). This report is for one reaming rod push rod with ball handle. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01458 |
| MDR Report Key | 9865859 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-23 |
| 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 | 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 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REAMING ROD PUSH ROD WITH BALL HANDLE |
| Generic Name | REAMER |
| Product Code | HTO |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 03.010.093 |
| Catalog Number | 03.010.093 |
| Lot Number | T958995 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-23 |