FDA Adverse Event
Malfunction
Summary report: N
2.0MM KIRSCHNER WIRE W/ DRILL TIP/100MM
MDR report key: 3131956
·
Received May 29, 2013
Report
- Report Number
- 2520274-2013-02851
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- April 30, 2013
- Report Date
- April 30, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HRS
- PMA / PMN Number
- K113364
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Additional Manufacturer Narrative · 1
ADDITIONAL NARRATIVE: GENDER "FEMALE" ADDED.
Description of Event or Problem · 1
THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Description of Event or Problem · 1
DURING A PROCEDURE ON (B)(6) 2013 INVOLVING AN EVALUATION ULNA OSTEOTOMY SET, A GUIDE PIN BECAME STUCK IN THE BLOCK DURING THE SURGICAL PROCEDURE. THIS ISSUE ADDED SEVEN TO EIGHT MINUTES TO THE PROCEDURE TIME. AN ALTERNATE SIZED BLOCK WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236165 | 2.0MM KIRSCHNER WIRE W/ DRILL TIP/100MM | HRS | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |