IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø6.0X400MM
Received Oct 30, 2024 · Event occurred Oct 7, 2024
Report 0009610622-2024-00897 · MDR key 20566205
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous
Manufacturer
Stryker GmbhCatalog number
02275060
Lot number
K0BA8D7
Product problems
- Break
- Fracture
- Break
- Fracture
Patient
24 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
FLEXIBLE REAMER BREAKAGE. ROOT OF 6.0 AND 8.0 REAMER BROKEN DURING DISTAL REAMING.
Additional Manufacturer Narrative
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative
THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE DEVICE WAS RETURNED BROKEN, AS REPORTED. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE RETURNED DEVICE SHOWS BROKEN SPIRALS AT THE BEGINNING OF THE SHAFT. SINCE NOT ALL SPIRALS HAVE BEEN BROKEN, THE DEVICE ITSELF HAS NOT DETACHED INTO SEVERAL PARTS. THE PORTION OF THE SHAFT CLOSE TO THE BREAKAGE IS HIGHLY TWISTED AND WORN OUT, WITH MULTIPLE SCRATCHES VISIBLE. THIS PLASTIC DEFORMATION INDICATES THE INSTRUMENT BROKE IN A DUCTILE WAY. THE FRACTURE MOST PROBABLY WAS INDUCES DUE TO AN INCREASED REPETITIVE TORSIONAL OVERLOAD, ULTIMATELY LEADING TO BREAKAGE. IT IS WORTH NOTING THAT THE REAMING TIP OF THE INSTRUMENT, ALTHOUGH HAVING SIGNS OF USE, DOES NOT SHOW ANY PARTICULAR SIGN OF DAMAGE. DIMENSIONAL INSPECTION HAS CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO AN USER RELATED ISSUE, CAUSED BY EXCESSIVE TORSIONAL BEING APPLIED TO THE REAMER. IN ADDITION, THE PRESENCE OR NOT OF A K-WIRE IS IMPOSSIBLE TO CONFIRM. AS A REMINDER, THE ABSENCE OF A K-WIRE CAN CAUSE AN UNCONTROLLED DRIFT OF THE REAMER, WHICH COULD HELP CAUSING THE BREAKAGE. AS STATED BY THE INSTRUCTIONS FOR USE: ALWAYS PERFORM INTRAMEDULLARY REAMING OVER A K-WIRE TO PREVENT THE REAMER FROM DRIFTING UNCONTROLLABLY . 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.
Description of Event or Problem
FLEXIBLE REAMER BREAKAGE. ROOT OF 6.0 AND 8.0 REAMER BROKEN DURING DISTAL REAMING.