HUNTER TENDON ROD 3MM X 24.5CM
Received Jun 20, 2022 · Event occurred May 17, 2022
Report 3010667733-2022-00215 · MDR key 14749070
Device
Generic name
Spatula, Orthopedic
Manufacturer
Wright Medical Technology IncModel number
TR300000Catalog number
TR300000
Lot number
1709893
Product problems
- Inaccurate Information
- Inaccurate Information
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED DURING THE PROCEDURE THAT THERE WAS A DISCREPANCY IN THE SIZE OF IMPLANT VS THE SIZE LISTED ON THE BOX.
Additional Manufacturer Narrative
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED DURING THE PROCEDURE THAT THERE WAS A DISCREPANCY IN THE SIZE OF IMPLANT VS THE SIZE LISTED ON THE BOX.
Additional Manufacturer Narrative
THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE RETURNED DEVICE IS CONFORMING TO SPECIFICATIONS AND FULLY FUNCTIONAL. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE DEVICE WAS RETURNED IN THE ORIGINAL CARTON. THE CARTON CONFIRMED THE CATALOG TO BE TR300000 AND LOT TO BE 1709893. THE CARTON WAS OPENED AND INSIDE THE HUNTER TENDON WAS IN THE INNER TYVEK POUCH IN AN OPENED STATE. THE LABEL ON THE INNER TYVEK POUCH ALSO CONFIRMS THE CATALOG AND LOT NUMBER. THE HUNTER TENDON WAS WHITE AND DID NOT EXHIBIT ANY ABNORMAL DAMAGE OR DEFORMATION. DIMENSIONAL MEASURMENTS TAKEN FOUND THE RETURNED DEVICE TO BE WITHIN SPECIFICATIONS. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. 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. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.