FDA Adverse Event
Malfunction
Summary report: N
1/4" DRILL WITH JACOBS CHUCK
MDR report key: 2121543
·
Received May 6, 2011
Report
- Report Number
- 1811755-2011-01628
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 13, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. BASED ON THE QUALITY INVESTIGATION DETAILS, THERE WAS SEVERE CORROSION DAMAGE TO THE BEARING AND THE BLACK RING. THE BLACK RING HAD EXPLODED, AND PARTICLES HAD FALLEN FROM THE CHUCK HEAD.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A KNEE PROCEDURE, METAL FLAKES FELL FROM THE DEVICE AND ENTERED THE SURGICAL SITE. THE SURGICAL SITE WAS CLEANED AND ALL THE METAL FLAKES WERE REMOVED. NO ADDITIONAL TREATMENT WAS ADMINISTERED TO THE PATIENT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1/4" DRILL WITH JACOBS CHUCK | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |