DJD BODY ASSEMBLY DISTRACTOR II
Received Jan 20, 2026 · Event occurred Dec 23, 2025
Report 0008031020-2026-00049 · MDR key 24122964
Device
Generic name
Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Com
Manufacturer
Stryker GmbhCatalog number
51950010
Lot number
AU3335
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem
AS REPORTED: "IT WAS SCHEDULED FOR USE IN SURGERY, BUT IT APPEARS THE HINGE PART CAME LOOSE DURING ASSEMBLY OF THE EXTERNAL FIXATOR."
Description of Event or Problem
AS REPORTED: "IT WAS SCHEDULED FOR USE IN SURGERY, BUT IT APPEARS THE HINGE PART CAME LOOSE DURING ASSEMBLY OF THE EXTERNAL FIXATOR."
Additional Manufacturer Narrative
CORRECTIONS: PLEASE REFER TO SECTIONS D9 THE DEVICE WAS RETURNED AND H6 (METHOD, RESULTS AND CONCLUSION CODES). 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 THE INSTRUMENT IS IN A WELL-USED CONDITION WITH SCRATCHES, DENT AND DEFORMATIONS. FURTHERMORE, THE HINGE IS IN A REALLY BAD CONDITION WITH FOREIGN SUBSTANCE (STICKY) AND DEFORMATION, FROM USE. IN ADDITION, MICROSCOPIC INVESTIGATION HAS SHOWN THAT THERE ARE CLEAR INDICATIONS THAT THE RADIALLY RIVETED (FLANGED) GOT DAMAGED AFTER MANUFACTURING AND BASED ON THAT WAS ABLE TO FALL OFF, THE SLEEVE SHOWS STRONG SIGNS OF WEAR FROM CONSTANT MOVEMENT. FUNCTIONAL EXAMINATION OF THE RECEIVED PRODUCT SHOWS THAT THE INSTRUMENT WAS RECEIVED WITH COMPLETELY BLOCKED ADJUSTMENTS MECHANISM IN FAR SHORT CONDITION, WITH FORCE WE WERE ABLE TO UNBLOCK THE INSTRUMENT. FURTHERMORE, WE ARE ABLE TO CONFIRM THAT THE HINGE CAN BE DISASSEMBLED, AS THE SLEEVE CAN BE REMOVED AND BASED ON THAT THE HINGE WILL FALL APART. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USE RELATED ISSUE. THE FAILURE WAS CAUSED MOST LIKELY BY THE COLLAPSE OF THE RADIALLY RIVETED AS RESULT OF CONTINUOUSLY MECHANICAL FORCE. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.