FDA Adverse Event
Malfunction
Summary report: N
FLEXIBLE REAMER
MDR report key: 85968
·
Received April 17, 1997
Report
- Report Number
- 1818910-1997-00088
- Event Type
- Malfunction
- Date Received
- April 17, 1997
- Date of Event
- March 7, 1997
- Report Date
- March 18, 1997
- Manufacturer
- DEPUY, INC.
- Product Code
- HTO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SUSPECT MEDICAL DEVICE (IE. FLEXIBLE REAMER) IS NOT A DEPUY ORTHOPAEDICS, INC. PRODUCT AS INITIALLY REPORTED. THIS WAS REPORTED IN ERROR. THE SUSPECT MEDICAL DEVICE IS A PRODUCT OF DEPUY ACE MEDICAL COMPANY. THE BASELINE REPORT ASSOCIATED WITH THIS MEDWATCH FORM DATED 4/1/97, IS VOID AND WILL NOT BE UPDATED.
Description of Event or Problem · 1
COMPLAINANT CLAIMS THE REAMER BECAME LODGED IN THE FEMUR AND BROKE DURING SURGERY. SURGERY WAS DELAYED APPROX 10-15 MINUTES BECAUSE OF THIS EVENT WHILE THE REAMER WAS REMOVED MANUALLY FROM THE FEMUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXIBLE REAMER | MANUAL ORTHOPAEDIC INSTRUMENT | HTO | DEPUY, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |