SPECIALIST 99-1016Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295253617), received between Oct 24, 2017 and Jul 5, 2023 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (18 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SP2 DROP ROD BENT. NO PIECES. SOME WILL BE RETURNED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263743 ↗
• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SP2 DROP ROD BENT. NO PIECES. SOME WILL BE RETURNED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261644 ↗
• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SP2 DROP ROD BENT. NO PIECES. SOME WILL BE RETURNED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261602 ↗
• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SP2 DROP ROD BENT. NO PIECES. SOME WILL BE RETURNED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261392 ↗
• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SP2 DROP ROD BENT. NO PIECES. SOME WILL BE RETURNED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261380 ↗
• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SP2 DROP ROD BENT. NO PIECES. SOME WILL BE RETURNED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261074 ↗
• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SP2 DROP ROD BENT. NO PIECES. SOME WILL BE RETURNED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259938 ↗
• MalfunctionJul 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SP2 DROP ROD BENT. NO PIECES. SOME WILL BE RETURNED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259927 ↗
• MalfunctionMay 8, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT BROKE FOR UNKNOWN REASONS. MOST LIKELY OCCURRED OVER TIME GRADUALLY FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888139 ↗
• MalfunctionMay 8, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT BROKE FOR UNKNOWN REASONS. MOST LIKELY OCCURRED OVER TIME GRADUALLY FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888118 ↗
• MalfunctionApr 18, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE PRIMARY TOTAL KNEE ARTHROPLASTY, THE SCRUB TECH OBSERVED THAT THE LONG ALIGNMENT ROD WAS SLIGHTLY BENT. THIS DID NOT EXTEND THE TIME OF SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766086 ↗
• MalfunctionFeb 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ALIGNMENT ROD IS SLIGHTLY BENT. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335402 ↗
• MalfunctionJan 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THERE WAS GRADUAL BENDING OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113470 ↗
• MalfunctionOct 21, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE ALIGNMENT ROD FOR THE OSTEOARTHRITIS OF THE KNEE. WHEN THE AGENT CHECKED THE PRODUCT, THE ALIGNMENT ROD WAS BENT. THERE WAS A POSSIBILITY THAT THE PRODUCT HAS BEEN BENT DUE TO FREQUENT USE OF INSTRUMENT. THE ALIGNMENT ROD WAS NOT USED FOR THE PATIENT SINCE IT WAS FOUND BEFORE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15653352 ↗
• MalfunctionAug 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ALIGNMENT ROD WAS BENT. THE ALIGNMENT ROD WAS NOT USED FOR THE PATIENT SINCE IT WAS FOUND BEFORE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203107 ↗
• MalfunctionMay 7, 2022Material Deformation; Material Deformation

  THE LONG ALIGNMENT ROD WAS BENT DURING SURGERY. IT DID NOT BREAK INTO TWO PIECES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316005 ↗
• MalfunctionMar 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE RODS WILL NOT CONNECT TO T HANDLE. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13724442 ↗
• MalfunctionMar 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE RODS WILL NOT CONNECT TO T HANDLE. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13724437 ↗
• MalfunctionFeb 15, 2022Break; Break

  THERE ARE MULTIPLE BROKEN ITEMS FROM PFC KIT. DISCOVERY WAS MADE OUTSIDE OF SURGERY. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539313 ↗
• MalfunctionJan 4, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON PLACED DROP RODS INTO TIBIAL ALIGNMENT HANDLE AND ASKED US TO REPLACE THEM BECAUSE HE SAID THEY ARE BENT. NO DELAY WAS CAUSED, THERE WAS NO NEGATIVE IMPACT ON THE OUTCOME. WE HAD BACKUP INSTRUMENTATION STERILE THAT FIT THE NEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152773 ↗
• MalfunctionJan 4, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON PLACED DROP RODS INTO TIBIAL ALIGNMENT HANDLE AND ASKED US TO REPLACE THEM BECAUSE HE SAID THEY ARE BENT. NO DELAY WAS CAUSED, THERE WAS NO NEGATIVE IMPACT ON THE OUTCOME. WE HAD BACKUP INSTRUMENTATION STERILE THAT FIT THE NEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152760 ↗
• MalfunctionMar 18, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE ALIGNMENT ROD WAS BENT. NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848506 ↗
• MalfunctionDec 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ROD IS BENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9519594 ↗
• MalfunctionFeb 11, 2019Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  TOTAL KNEE REPLACEMENT - EXTERNAL ALIGNMENT ROD ON SIGMA PFC SPEC 2 INSTRUMENT TRAY WAS BENT. UNABLE TO USE TO DOUBLE CHECK INTRAMEDULLARY ALIGNMENT. PATIENT WAS UNAFFECTED, SURGEON CARRIED ON WITH PROCEDURE. NO DELAY IN SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325920 ↗
• MalfunctionFeb 11, 2019Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  TOTAL KNEE REPLACEMENT - EXTERNAL ALIGNMENT ROD ON SIGMA PFC SPEC 2 INSTRUMENT TRAY WAS BENT. UNABLE TO USE TO DOUBLE CHECK INTRAMEDULLARY ALIGNMENT. PATIENT WAS UNAFFECTED, SURGEON CARRIED ON WITH PROCEDURE. NO DELAY IN SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325919 ↗