SPECIALIST 96-6112Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295246855), received between Feb 28, 2018 and Mar 1, 2022 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  THE HOSPITAL HAS REPORTED THAT THE INSTRUMENT WAS VERY WORN IN A NUMBER OF TRAYS AND THE SURGEON WAS UNABLE TO SEE THE MARKINGS CLEARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633949 ↗
• MalfunctionMar 1, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  THE HOSPITAL HAS REPORTED THAT THE INSTRUMENT WAS VERY WORN IN A NUMBER OF TRAYS AND THE SURGEON WAS UNABLE TO SEE THE MARKINGS CLEARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633939 ↗
• MalfunctionMar 1, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  THE HOSPITAL HAS REPORTED THAT THE INSTRUMENT WAS VERY WORN IN A NUMBER OF TRAYS AND THE SURGEON WAS UNABLE TO SEE THE MARKINGS CLEARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633557 ↗
• MalfunctionMar 1, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  THE HOSPITAL HAS REPORTED THAT THE INSTRUMENT WAS VERY WORN IN A NUMBER OF TRAYS AND THE SURGEON WAS UNABLE TO SEE THE MARKINGS CLEARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633551 ↗
• MalfunctionMar 1, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  THE HOSPITAL HAS REPORTED THAT THE INSTRUMENT WAS VERY WORN IN A NUMBER OF TRAYS AND THE SURGEON WAS UNABLE TO SEE THE MARKINGS CLEARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633523 ↗
• MalfunctionMar 1, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  THE HOSPITAL HAS REPORTED THAT THE INSTRUMENT WAS VERY WORN IN A NUMBER OF TRAYS AND THE SURGEON WAS UNABLE TO SEE THE MARKINGS CLEARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633509 ↗
• MalfunctionMay 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  MATCH ISSUE. IT WAS REPORTED THAT AS THE EVENT (B)(4) HAPPENED, CONSIDERING SAFETY, THE DISTRIBUTOR CHECKED THE SAME LOT PRODUCTS, NOTED THE IMPACT PRODUCTS ALSO WITH THE SAME ISSUE AS THE PHOTO SHOWS: 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10061468 ↗
• MalfunctionMay 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  MATCH ISSUE. IT WAS REPORTED THAT AS THE EVENT (B)(4) HAPPENED, CONSIDERING SAFETY, THE DISTRIBUTOR CHECKED THE SAME LOT PRODUCTS, NOTED THE IMPACT PRODUCT ALSO WITH THE SAME ISSUE: 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10057143 ↗
• MalfunctionMay 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  MATCH ISSUE. IT WAS REPORTED THAT AS THE EVENT (B)(4) HAPPENED, CONSIDERING SAFETY, THE DISTRIBUTOR CHECKED THE SAME LOT PRODUCTS, NOTED THE IMPACT PRODUCT ALSO WITH THE SAME ISSUE: 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10052943 ↗
• MalfunctionMay 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  MATCH ISSUE. IT WAS REPORTED THAT AS THE EVENT (B)(4) HAPPENED, CONSIDERING SAFETY, THE DISTRIBUTOR CHECKED THE SAME LOT PRODUCTS, NOTED THE IMPACT PRODUCT ALSO WITH THE SAME ISSUE: 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10052934 ↗
• MalfunctionMay 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  MATCH ISSUE. IT WAS REPORTED THAT DURING THE PFC OPERATION, NOTED 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. NO BACK-UP TOOLS ON THE SITE, THE SURGEON CUT THE BONE IN ACCORDING TO HIS EXPERIENCES. THE SURGERY DELAYED ABOUT 40MINS. THE PATIENT IS STABLE AND IN HOSPITAL NOW. THESE TWO TOOLS WERE 1ST TIME USE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10044846 ↗
• MalfunctionMay 8, 2020Device-Device Incompatibility; Device-Device Incompatibility

  MATCH ISSUE. IT WAS REPORTED THAT AS THE EVENT (B)(4) HAPPENED, CONSIDERING SAFETY, THE DISTRIBUTOR CHECKED THE SAME LOT PRODUCTS, NOTED THE IMPACT PRODUCT ALSO WITH THE SAME ISSUE: 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10039646 ↗
• MalfunctionMay 8, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A MATCH ISSUE. THE LOCATG DEV OUTRIGGER COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF THE FEM CUTTING BLOCK. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10039120 ↗
• MalfunctionMay 8, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A MATCH ISSUE. THE LOCATG DEV OUTRIGGER COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF THE FEM CUTTING BLOCK. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10039103 ↗
• MalfunctionNov 4, 2019Device-Device Incompatibility; Mechanical Jam; Physical Resistance/Sticking; Device-Device Incompatibility; Mechanical Jam; Physical Resistance/Sticking

  SP2 DISTAL FEM CUTTING BLOCK CAN'T BE MATCHED WITH (966112) SP*2 FEM LOCATG DEV OUTRIGGER BECAUSE IT GETS STUCK. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9274568 ↗
• MalfunctionOct 9, 2019Material Deformation; Naturally Worn; Unintended Movement; Material Deformation; Naturally Worn; Unintended Movement

  THE PARTS DON'T CLIP WELL TOGETHER. THE MEASURE IS NOT GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9171767 ↗
• MalfunctionFeb 28, 2018Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE TWO PIECES ARE NOT MATING TOGETHER AND NEED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7302321 ↗