FDA Adverse Event
Malfunction
Summary report: N
TC MAYO-HEGAR NDL HOLDERHVYSERR185MM
MDR report key: 5046424
·
Received August 13, 2015
Report
- Report Number
- 2916714-2015-00751
- Event Type
- Malfunction
- Date Received
- August 13, 2015
- Report Date
- January 13, 2016
- Manufacturer
- AESCULAP AG & CO. KG
- Product Code
- HXK
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING SITE EVALUATION: PRODUCT RECEIVED WITH ONE OF THE HARD METAL INLAYS IS BROKEN 2 MM FROM THE TIP. INVESTIGATION WAS COMPLETED VISUALLY, USING THE DIGITAL MICROSCOPE. THIS FAILURE IS USER/MAINTENANCE RELATED. THE TIP OF THE CARBIDE METAL MAY HAVE BROKEN OFF DUE TO A NEEDLE BEING PICKED UP AND IT SLIPPED OFF THE NEEDLE HOLDER OR BY AGGRESSIVE MAINTENANCE METHODS, THE SOLDER AREA MAY HAVE DISSOLVED, RESULTING IN THE CARBIDE METAL BEING BRITTLE. CORRECTIVE / PREVENTIVE ACTION(S): NOT APPLICABLE.
Additional Manufacturer Narrative · 1
MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem · 1
FACILITY REPORTS THE DEVICE BROKE DURING SURGERY AND A PIECE WAS LOST INSIDE THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538118 | TC MAYO-HEGAR NDL HOLDERHVYSERR185MM | NEEDLE HOLDER | HXK | AESCULAP AG & CO. KG | BM066R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |