FDA Adverse Event
Malfunction
Summary report: N
HOFFMAN CONNECTING ROD
MDR report key: 1621911
·
Received February 5, 2010
Report
- Report Number
- 8031020-2009-00148
- Event Type
- Malfunction
- Date Received
- February 5, 2010
- Date of Event
- March 1, 2007
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTHESIS
- Product Code
- JEC
- 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
AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (DEVICE BROKE OR DISASSEMBLED DURING USE) AND PRODUCT CODE (B) (4).
Description of Event or Problem · 1
DEVICE BROKE OR DISASSEMBLED DURING USE. THE NURSE REPORTED THAT WHEN THE CARBON ROD IS DRIED, A SPLINTER (1CM) CAME LOOSE AND PENETRATED THE FINGER. SIMILAR INCIDENTS HAD OCCURRED THREE TIMES BEFORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOFFMAN CONNECTING ROD | IMPLANT | JEC | STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTHESIS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |