FDA Adverse Event
Malfunction
Summary report: N
SIZE 1.3 KEEL PUNCH GUIDE
MDR report key: 1962840
·
Received December 22, 2010
Report
- Report Number
- 2249697-2010-01881
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- November 30, 2010
- Report Date
- November 30, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).
Description of Event or Problem · 1
(B)(6), HEAD OF THE CENTRAL STERILIZATION DEPARTMENT, REPORTED VIA OUR SALES REP, (B)(6), THAT DESPITE A CONSTANT STERILIZATION PROCESS, THE PLASTIC GRIPS OF THE INSTRUMENTS DISSOLVE. PARTS DROP OFF. FOR CLEANING ARE (B)(4) FROM DR (B)(6) USED. LOOSE PARTS COULD REACH THE OPERATION AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIZE 1.3 KEEL PUNCH GUIDE | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |