FDA Adverse Event
Malfunction
Summary report: N
PRESSURE SENTINAL IM FLEXIBLE REAMER
MDR report key: 3871254
·
Received April 16, 2014
Report
- Report Number
- 1822565-2014-00493
- Event Type
- Malfunction
- Date Received
- April 16, 2014
- Date of Event
- March 18, 2014
- Report Date
- March 18, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: SPECIFIC SURGICAL CONDITIONS AND TECHNIQUES ARE NOT KNOWN. THE REAMER HEAD COULD HAVE POSSIBLY FRACTURED DUE TO ECCENTRIC LOADING AND IMPROPER BENDING DURING USE. THE ROOT CAUSE OF THE FRACTURE WAS LIKELY DUE TO USER ERROR OR HUMAN FACTORS. THE DEVICE MET PRINT SPECIFICATIONS WHERE MEASURED. THE REAMER HEAD WAS NOT RETURNED AND COULD NOT BE USED TO HELP IDENTIFY USE HISTORY BY INSPECTING WEAR. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATIONS.
Description of Event or Problem · 1
IT IS REPORTED THAT THE REAMER BROKE DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233789 | PRESSURE SENTINAL IM FLEXIBLE REAMER | HWE | ZIMMER, INC. | 60879777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |