SPECIALIST 96-6242Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295247425), received between Apr 17, 2020 and Jul 21, 2020 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304524 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE AFFECTED ITEMS WERE NEW AND IN PACKAGING AND WERE REMOVED AND ISOLATED WITHIN THE INVENTORY CAGE. THIS WOULD MEAN THAT FOR THESE PARTICULAR ITEMS WERE NOT USED IN SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304507 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304494 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE (B)(4) DC VIA (B)(4) USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304493 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304490 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304486 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE (B)(4) DC VIA (B)(4) USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304482 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304458 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301964 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301957 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301956 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301952 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE (B)(4) DC VIA (B)(4) USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301950 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301948 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301947 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301946 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE (B)(4) DC VIA (B)(4) USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301945 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  I HAVE BEEN NOTIFIED TODAY THAT ITEM 966242 LOT S0202933 A/P & CHAMFER CUTTING BLOCK W/REMOVABLE HANDLE HAS NAIL LIKE SHARP OBJECTS POTENTIALLY PROTRUDING FROM THEM. I BELIEVE THE PRODUCT ARRIVED AT THE TINGLEY DC VIA WARSAW USA AND ALL 10 WERE FOUND TO BE IN THIS CONDITION. THE AREA TEAM LEADER HAS ISOLATED THE PRODUCT AND REMOVED 8 MORE THAT WERE IN STOCK TO THE INVENTORY CAGE AWAITING FURTHER INSTRUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301941 ↗
• MalfunctionApr 17, 2020Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE SET OF SPECIALIST 1 CUTTING BLOCKS NEED TO BE REPLACED TO ROWAN / CHALMFERS ARE NOT ACCEPTING SAW BLADES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9973212 ↗