FDA Adverse Event
Injury
Summary report: N
11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
MDR report key: 3173028
·
Received June 17, 2013
Report
- Report Number
- 1719045-2013-01626
- Event Type
- Injury
- Date Received
- June 17, 2013
- Report Date
- May 20, 2013
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HSB
- PMA / PMN Number
- K011857
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.
Description of Event or Problem · 1
PATIENT EXPERIENCED PAIN AFTER THE BLADE IMPLANT CUT OUT FROM A PRIOR LEFT HIP SURGERY (UNKNOWN DATE). ON (B)(6) 2013, A REVISIONARY TOTAL HIP REPLACEMENT WAS PERFORMED AFTER THE SHORT TROCHANTERIC FIXATION NAIL WAS REMOVED. OTHER PARTS REMOVED INCLUDED A HELICAL BLADE AND 5.0 MM LOCKING SCREW. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273102 | 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE | HSB | SYNTHES MONUMENT | 6727840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |