FDA Adverse Event
Malfunction
Summary report: N
ANSPACH BLACK MAX SYSTEM
MDR report key: 4173256
·
Received October 15, 2014
Report
- Report Number
- 1045834-2014-13702
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Report Date
- November 13, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- ERL
- PMA / PMN Number
- PK831756
- 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 OUS 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 INSPECTION, TECHNICIAN FOUND DEVICE TOO SLOW WITH RPM BELOW SPECIFICATION DUE TO NORMAL WEAR, AND HOSE BRITTLE. FAILED SPEED TEST, FAILED NOISE TEST. HOSE, PLATE, BEARING, AND SEALS REPLACED.
Description of Event or Problem · 1
CUSTOMER REPORTED DEVICE DOES NOT WORK WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655634 | ANSPACH BLACK MAX SYSTEM | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |