FDA Adverse Event
Malfunction
Summary report: N
SPECIALTY TRIATHLON PKR 8/9MM UNIVERSAL INSERT TRIAL PER FILE K2728
MDR report key: 3093889
·
Received May 6, 2013
Report
- Report Number
- 0002249697-2013-01556
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 12, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MEH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN EVENT REGARDING FRACTURE INVOLVING A SPECIALTY TRIATHLON PKR 8/9MM UNIVERSAL INSERT TRIAL PER FILE (B)(4) WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED. THE REPORTED DEVICE IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TRIAL WAS BROKEN WHEN THE SURGEON REMOVED IT AFTER THE TRIAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TRIAL WAS BROKEN WHEN THE SURGEON REMOVED IT AFTER THE TRIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196810 | SPECIALTY TRIATHLON PKR 8/9MM UNIVERSAL INSERT TRIAL PER FILE K2728 | INSTRUMENT | MEH | STRYKER ORTHOPAEDICS-MAHWAH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |