FDA Adverse Event
Malfunction
Summary report: N
ANSPACH® XMAX
MDR report key: 4120637
·
Received September 26, 2014
Report
- Report Number
- 1045834-2014-13029
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Report Date
- December 27, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- ERL
- PMA / PMN Number
- PK131053
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, INVESTIGATION REVEALED THE DEVICE HOSE WAS TORN NEAR THE BRACKET. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER ON (B)(4) 2013. MFR DATE:MAY 2012.
Description of Event or Problem · 1
CUSTOMER REPORTED THE DEVICE DOES NOT ROTATE PROPERLY AND THE PRESENCE OF AN AIR LEAKING SOUND. THIS IS REPORT 1 OF 1 FOR #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600855 | ANSPACH® XMAX | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |