IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM
Received Nov 23, 2024 · Event occurred Nov 1, 2024
Report 0009610622-2024-00925 · MDR key 20766527
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous
Manufacturer
Stryker GmbhCatalog number
02276080
Lot number
K16EE2F
Product problems
- Break
- Fracture
- Material Deformation
- Break
- Fracture
- Material Deformation
Patient
14 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
AS REPORTED: "THE TIP OF THE 8 MM REAMER SHAFT WAS DAMAGED."
Additional Manufacturer Narrative
THE REPORTED EVENT COULD BE CONFIRMED SINCE THE PHYSICAL EXAMINATION REVEALED A BROKEN IM REAMER, MOD. TRINKLE FITTING BIXCUT 08,0X480MM. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE DEVICE IN QUESTION PRESENTS A FULLY BROKEN OFF REAMER HEAD. THE BROKEN OFF PART WAS ALSO RETURNED. FLEXIBLE SHAFT SHOWS SLIGHT BENDING IN THE FIRST THIRD OF THE FLEXIBLE AREA OF THE REAMER SHAFT AS SEEN FROM THE DIRECTION OF THE DRILL HEAD. AT THE TRANSITION FROM THE RIGID TO THE FLEXIBLE SHAFT AREA THE REAMER HEAD WAS COMPLETELY BROKEN OFF. THE ADAPTER COUPLING FOR POWER TOOL PRESENTS CLEAR SIGNS OF USAGE. THE REAMER HEAD PRESENTS SIGNS OF DAMAGE. THE INNER SURFACE HAS CIRCUMFERENTIAL TRACES OF EVIDENT RIDGE MARKS. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE EVENT WAS CAUSED BY IMPROPER HANDLING DURING PROCEDURE. UTMOST LIKELY DUE TO HEAVY CONTACT BY INTRODUCED K-WIRE DURING USE OF POWER TOOL IN NON-PERFECT FORM-FIT THE ITEM SLIGHTLY STUCK AND DUE TO FURTHER USE OF ROTARY MOTION WITH POWER TOOL THE HEAD FINALLY TORN-OFF. FINALLY, THE IFU ALSO POINTS OUT: ENSURE THAT BONE DEBRIS DOES NOT ACCUMULATE IN THE CANNULATION OF THE INSTRUMENT TO REDUCE THE RISK OF INSTRUMENT BINDING ON THE K-WIRE. 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. IN CASE SUBSTANTIVE INFORMATION WILL BECOME AVAILABLE IN FUTURE THAT SUGGESTS OTHERWISE WE RESERVE THE RIGHT TO REOPEN THE CASE.
Description of Event or Problem
AS REPORTED: "THE TIP OF THE 8 MM REAMER SHAFT WAS DAMAGED".