FDA Adverse Event
Malfunction
Summary report: N
SIZE 4-8 KEEL PUNCH GUIDE
MDR report key: 2369161
·
Received November 9, 2011
Report
- Report Number
- 2249697-2011-01567
- Event Type
- Malfunction
- Date Received
- November 9, 2011
- Date of Event
- October 11, 2011
- Report Date
- October 13, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE SURGERY NURSE (B)(6) HAS REPORTED TO THE SALES REP PER OLOF BRETTMAR THAT THE POSTERIOR LOCKING PART CAME LOSS FROM INSTRUMENT DURING IMPACTION OF KIL PREPARATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIZE 4-8 KEEL PUNCH GUIDE | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | NYC01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |