FDA Adverse Event
Malfunction
Summary report: N
CONNECTING ROD HOFFMANN II MICRO Ø 3 X 60MM
MDR report key: 25317818
·
Received May 28, 2026
Report
- Report Number
- 0008031020-2026-00722
- Event Type
- Malfunction
- Date Received
- May 28, 2026
- Date of Event
- October 31, 2025
- Report Date
- May 28, 2026
- Manufacturer
- STRYKER GMBH
- Product Code
- KTT
- UDI-DI
- 04546540389923
- PMA / PMN Number
- K033476
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE COMPLAINT COULD BE CONFIRMED, SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: VISUAL EXAMINATION OF THE RECEIVED PRODUCT SHOWS THAT BOTH ENDS HAVE FINE CRACKS, AS REPORTED. OTHERWISE, THE PART IS IN A GOOD AND NOT DAMAGED CONDITION. INSPECTION OF THE RECEIVED INFORMATION/EVIDENCE ARE DONE OR WILL BE DONE, IN THE PROCEEDINGS OF THE NC. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A DESIGN RELATED ISSUE.
Description of Event or Problem · 0
AS REPORTED: "DURING INSPECTIONS FOR PQH (B)(4) FURTHER CRACKS WERE NOTICED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326964 | CONNECTING ROD HOFFMANN II MICRO Ø 3 X 60MM | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | KTT | STRYKER GMBH | 26125H | 04546540389923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |