MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-16 for 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM 292.71 manufactured by Wrights Lane Synthes Usa Products Llc.
[183706460]
Additional product code: ktt. Complainant part is not expected to be returned for manufacturer review/ investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; 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
[183706461]
It was reported that on (b)(6) 2017, the patient underwent an open reduction and internal fixation of right olecranon nonunion with distal radius autograft, removal of right radial head prosthetic secondary to loosening, revision right radial head arthroplasty and removal of failed tension band construct. The implants removed were synthes radial head prosthetic and tension band wire construct wherein two (2) k-wires were loose. On (b)(6) 2016, after sustaining a fall which resulted in an olecranon and comminuted radial head fracture, the patient underwent an open reduction and internal fixation of olecranon fracture and endo-prosthetic replacement of the proximal radius. The patient was implanted with a synthes radial head and stem. Post-operatively, the patient had improvement but started noting worsening pain and issues with her hardware. On (b)(6) 2016, the patient underwent a partial removal of the exposed hardware from the tension band wiring but was not fully removed since there was no concern for infection. On (b)(6) 2017, during a doctor's visit, the patient continues to report that she is back to doing all of her normal activities without restrictions. She is having only occasional discomfort in cold weather, but this is completely tolerable. This is 1 of 2 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01285 |
| MDR Report Key | 9834961 |
| Report Source | OTHER |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-27 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2020-03-06 |
| 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 |
| 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 | 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM |
| Generic Name | BONE PLATE |
| Product Code | JEY |
| Date Received | 2020-03-16 |
| Model Number | 292.71 |
| Catalog Number | 292.71 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-16 |