FDA Adverse Event
Malfunction
Summary report: N
2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM
MDR report key: 3173618
·
Received June 17, 2013
Report
- Report Number
- 8030965-2013-03328
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 21, 2013
- Report Date
- May 21, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- HTW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Description of Event or Problem · 1
DRILL BIT BROKE DURING REPAIR OF A DISTAL HUMERUS FRACTURE, TIP WAS RETAINED IN THE PATIENT'S BONE. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273142 | 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM | BIT, DRILL | HTW | SYNTHES GMBH | 8411420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |