FDA Adverse Event
Malfunction
Summary report: N
2.5MM DRILL BIT/QC/GOLD/110MM
MDR report key: 3024967
·
Received March 28, 2013
Report
- Report Number
- 1719045-2013-00705
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 27, 2013
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HTW
- PMA / PMN Number
- K962913
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODE HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
ON (B)(6) 2013, DURING A DISTAL TIBIA PLATE INSERTION, A DRILL BIT BROKE OFF INTO THE OPERATING SITE. DRILL BIT REMAINS EMBEDDED IN PATIENT. NO FRAGMENTS OR X-RAYS AVAILABLE AT THIS TIME. THE PROCEDURE WAS INTENDED TO ADDRESS AN ACUTE FRACTURE. NO DELAY TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128390 | 2.5MM DRILL BIT/QC/GOLD/110MM | HTW | SYNTHES MONUMENT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |