FDA Adverse Event
Malfunction
Summary report: N
4.5MM CANNULATED SCREW PARTIALLY THREADED/56MM
MDR report key: 2033665
·
Received March 23, 2011
Report
- Report Number
- 1719045-2011-00133
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- January 30, 2011
- Report Date
- February 28, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HWC
- PMA / PMN Number
- K963172
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.
Description of Event or Problem · 1
MEDWATCH (B)(4) RECEIVED ON A OPEN REDUCTION OF HUMERUS FRACTURE REPORTS: AS SURGEON WAS INSERTING A 4.5 MM CANNULATED SCREW PARTIALLY THREADED 56 MM INTO THE PT'S ELBOW, PIECES OF THE SCREW THREAD BEGAN TO BREAK OFF INTO THE PATIENT'S BONE. BODY OF THE SCREW RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.5MM CANNULATED SCREW PARTIALLY THREADED/56MM | CANNULATED SCREWS | HWC | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |