FDA Adverse Event
Malfunction
Summary report: N
ORTHOPEDIC 2POUND/1POUND MALLET
MDR report key: 3532515
·
Received October 28, 2013
Report
- Report Number
- 3005236665-2013-00010
- Event Type
- Malfunction
- Date Received
- October 28, 2013
- Date of Event
- September 30, 2013
- Report Date
- October 10, 2013
- Manufacturer
- KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL
- Product Code
- GFJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE SAMPLE HAS NOT BEEN REC'D BY MFR IN TIME FOR THIS REPORT.
Description of Event or Problem · 1
THE COMPLAINT WAS REPORTED AS: COMPLAINT ALLEGES: DURING A TOTAL JOINT PROCEDURE, THE HEAD FLEW OFF THE SHAFT OF THE INSTRUMENT. THERE WAS NO MEDICAL INTERVENTION. NO PT OR MEDICAL STAFF INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553655 | ORTHOPEDIC 2POUND/1POUND MALLET | ORTHOPEDIC MALLET | GFJ | KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |