FDA Adverse Event
Malfunction
Summary report: N
DRILL PIN CAS FIX PIN 3.2D X 150MM STR
MDR report key: 19859951
·
Received July 30, 2024
Report
- Report Number
- 19859951
- Event Type
- Malfunction
- Date Received
- July 30, 2024
- Date of Event
- June 10, 2024
- Report Date
- June 18, 2024
- Manufacturer
- ZIMMER CAS
- Product Code
- OLO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ME
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
FROM STAFF: DURING A TOTAL KNEE ARTHROPLASTY, THE SURGEON WAS INSERTING A DRILL PIN AT THE SURGICAL SITE WHEN IT BROKE INTO 2 PIECES. ONE OF THE PIECES WAS STILL IN THE PATIENT AND IT WAS DISCOVERED IMMEDIATELY. THE SURGEON WAS ABLE TO SAFELY REMOVE THE IMBEDDED PIECE. FROM OPERATIVE REPORT: ONE FEMORAL PIN SHEARED IN HALF. THE BROKEN PORTION WAS FOUND WITHIN THE SOFT TISSUE. THE SECOND PIN THAT WAS USED HELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230316 | DRILL PIN CAS FIX PIN 3.2D X 150MM STR | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | ZIMMER CAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female |