FDA Adverse Event
Malfunction
Summary report: N
2520274-2013-02203
MDR report key: 3082079
·
Received April 29, 2013
Report
- Report Number
- 2520274-2013-02203
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 2, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE ON (B)(6) 2013, THE LOCKING SCREW WOULD NOT FULLY ENGAGE WITH THE PLATE WHEN IT WAS INSERTED. THERE WAS ONLY A TWO MINUTE DELAY AND NO HARM TO PATIENT WAS NOTED. A CANCELLOUS SCREW WAS USED INSTEAD TO HOLD THE PLATE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183812 | HRS | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |