FDA Adverse Event
Injury
Summary report: N
K-WIRE STAINLESS STEEL OLIVE K-WIRE
MDR report key: 23809926
·
Received December 15, 2025
Report
- Report Number
- MW5180536
- Event Type
- Injury
- Date Received
- December 15, 2025
- Date of Event
- December 8, 2025
- Report Date
- December 9, 2025
- Manufacturer
- MEDARTIS INC.
- Product Code
- GDF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
TIP BROKE UPON REMOVAL FROM PATIENT. ALL PIECES WERE RETRIEVED. NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2038752 | K-WIRE STAINLESS STEEL OLIVE K-WIRE | GUIDE, NEEDLE, SURGICAL | GDF | MEDARTIS INC. | A-5045.41/1 | 67446521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention |