FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
MDR report key: 3694540
·
Received March 24, 2014
Report
- Report Number
- 0001811755-2014-00987
- Event Type
- Malfunction
- Date Received
- March 24, 2014
- Date of Event
- February 24, 2014
- Report Date
- February 26, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- GFF
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE RETURN REQUESTED, IF THE DEVICE IS MADE AVAILABLE FOR RETURN A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. PRODUCT RETURN REQUESTED BUT NOT YET RECEIVED.
Additional Manufacturer Narrative · 1
DEVICE RETURNED, EVALUATION COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BLADE BROKE DURING A PROCEDURE. THE COMPLAINANT WAS NOT AWARE OF ANY SURGICAL DELAY, MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BLADE BROKE DURING A PROCEDURE. THE COMPLAINANT WAS NOT AWARE OF ANY SURGICAL DELAY, MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171984 | UNKNOWN_INSTRUMENTSTIRE_PRODUCT | UNKNOWN | GFF | STRYKER INSTRUMENTS-KALAMAZOO | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4), LOT 0921705263| (B)(4), LOT 0921705263 |