MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-03 for 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM 292.20 manufactured by Wrights Lane Synthes Usa Products Llc.
[181826169]
Additional device product code: lrn. Complainant part is not expected to be returned for manufacturer review/ investigation. Reporter is patient's relative. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[181826170]
It was reported that on an unknown date of 2010, a patient underwent a surgery due to a left patellar fracture. Patient's hardware which was a 1. 6 mm k-wire and 2. 0mm k-wire were broken postoperatively. Another surgery was done on an unknown date. No further information is provided. This report is for one (1) 2. 0 mm kirschner wire w/trocar point 150 mm. This is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01112 |
| MDR Report Key | 9781085 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-07 |
| Date Mfgr Received | 2020-04-02 |
| Date Added to Maude | 2020-03-03 |
| 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 | ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM |
| Generic Name | PIN,FIXATION,SMOOTH |
| Product Code | HTY |
| Date Received | 2020-03-03 |
| Model Number | 292.20 |
| Catalog Number | 292.20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2020-03-03 |