REFLECTION 71362290Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010454171), received between Aug 12, 2019 and Mar 23, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SHAFT OF A REFLECTION FLEXIBLE SCREWDRIVER SNAPPED WHILE INSERTING CENTER MANHOLE COVER. NO ISSUES RESULTED FROM BREAKAGE. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNSPECIFIED. THEREFORE, PATIENT INVOLVEMENT IS YET TO BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866631 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED THAT A REFLECTION FLEXIBLE SCREWDRIVER IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616029 ↗
• MalfunctionFeb 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THR PROCEDURE THE FLEXIBLE SCREWDRIVER IS BENT AND NEEDS TO BE REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH AN SMITH&NEPHEW BACKUP DEVICE. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356741 ↗
• MalfunctionFeb 19, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THR PROCEDURE THE FLEXIBLE SCREWDRIVER IS BENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH AN SMITH&NEPHEW BACKUP DEVICE. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347215 ↗
• MalfunctionJan 25, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, A FLEXIBLE SCREWDRIVER WAS FOUND TO BE STRIPPED AND WORN. INCIDENT OCCURRED DURING AN OFFICE INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222278 ↗
• MalfunctionSep 23, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION THE FLEXIBLE SCREWDRIVER WAS FOUND TWISTED. NO CASE RELATED, THEREFORE NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10576799 ↗
• MalfunctionAug 12, 2019Break; Break

  IT WAS REPORTED THAT DR NEEDED A STRAIGHT SCREWDRIVER TO PUT IN THE CUP AND THERE WASN¿T ONE IN THE TRAY. SO A FLEXIBLE ONE WAS USED AND IT BROKE IN THE SHAFT REGION BECAUSE THE TORQUE HE WAS TRYING TO USE IT IN WAS TOO HIGH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8882995 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a