NA 03.100.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982070678), received between May 30, 2019 and Jan 26, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Contamination /Decontamination Problem

  IT WAS REPORTED MULTIPLE DEVICES ARE NO LONGER FUNCTIONAL. THESE ISSUES DID NOT IMPACT PATIENT OUTCOMES. BELOW DEVICES WERE FOUND TO BE "RELEASE MECHANISM BROKEN" DURING INSPECTION: 03.043.028. BELOW DEVICES WERE FOUND TO BE "STRIPPED THREADS" DURING INSPECTION: 03.120.022, 312.648, 323.029. BELOW DEVICES WERE FOUND TO BE "NUT STUCK ON SLEEVE" DURING INSPECTION: 03.037.017, 03.037.016. BELOW DEVICES WERE FOUND TO BE "HANDLE LEACHING/SPD WIL NOT STERILIZE" DURING INSPECTION: 03.100.018. BELOW DEVICES WERE FOUND TO BE "BROKEN HANDLE" DURING INSPECTION: 311.43. BELOW DEVICES WERE FOUND TO BE "STRIPPED DRILL CONNECTION AND 2ND IS COLD WELDED TO A SCHANZ PIN" DURING INSPECTION: 393.103. BELOW DEVICES WERE FOUND TO BE "BROKEN SLIDING MECHANISM" DURING INSPECTION: 319.091. BELOW DEVICES WERE FOUND TO BE "NOT SNAPPING IN" DURING INSPECTION: 03.120.018, 03.120.017. BELOW DEVICES WERE FOUND TO BE "STRIPPED" DURING INSPECTION: 03.010.151, 314.467, 03.900.042, 03.130.010, 314.453, 03.010.150, 03.010.152. BELOW DEVICES WERE FOUND TO BE "NOT WORKING PROPERLY" DURING INSPECTION: 329.15. BELOW DEVICES WERE FOUND TO BE "NOT LOCKING TENSION BETWEEN TRIGGER PULLS" DURING INSPECTION: 03.221.015. BELOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179635 ↗
• MalfunctionJul 1, 2025Crack; Crack

  IT WAS REPORTED THAT THE WOOD HANDLE WAS CRACKED NEAR THE BOTTOM OF THE HANDLE. THE PRODUCT DAMAGE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375015 ↗
• MalfunctionApr 17, 2025Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  DURING THE PROCEDURE, IT IS SEEN THAT THE STRAIGHT REDUCER PUNCH 6.5 L300 AT ITS TIP IS DAMAGED AND WORN. IT ALSO HAPPENS THAT DURING SURGERY THE MALLEABLE TEMPLATE O / PL RECO LOW PROFILE 3.5 CURVED OF THE EQUIPMENT IS DAMAGED, IT BREAKS WHEN THE DOCTOR IS USING IT AS A GUIDE TO MOLD THE PLATE. FOR ALL THE AFOREMENTIONED THERE IS NO DISCOMFORT FOR THE SPECIALIST, THERE ARE NO ALTERATIONS IN SURGICAL TIMES, NOR AFFECTATIONS TO THE PATIENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY BECAUSE THERE WAS MORE MATERIAL INSIDE THE EQUIPMENT TO REPLACE THE DAMAGED ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856527 ↗
• MalfunctionApr 13, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE WOOD HANDLED INSTRUMENTS ARE LEAVING A STAIN/RESIDUE WHEN THEY ARE PEEL-PACKED AND STERILIZED. THERE WERE NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR ONE (1) STR BALL SPIKE FOR LOW PRO PELVIC SYS. THIS IS REPORT 5 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738387 ↗
• InjuryNov 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF FOR DISLOCATED FRACTURE OF THE SACROILIAC JOINT WITH THE PRODUCTS IN QUESTION. DURING THE RECONSTRUCTION PROCESS, WHEN THE TREATE BALL SPIKE AND SPIKE DISC WERE USED IN COMBINATION, DEEP BLOOD VESSELS WERE INJURED DUE TO THE SLIPPAGE OF THE PRODUCTS. THE PATIENT WAS IMMEDIATELY TREATED IN THE ANGIOGRAPHY ROOM, FOLLOWED BY PLATE FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 40 MINUTES. THE SCHEDULED SURGERY TIME WAS 3 HOURS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Perforation of Vessels

  MAUDE report 15723542 ↗
• MalfunctionApr 29, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THE ITEMS WERE REPORTED TO BE FOUND BROKEN DURING ROUTINE INSPECTION. NO KNOWN PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT IS FOR A STRIKE BALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251819 ↗
• MalfunctionMay 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE NON-ACCEPTANCE OF THE INSTRUMENT WITH CABLE IN CELERON MATERIAL BY THE (B)(6) HOSPITAL MATERIALS CENTER, WE CONSULTED WITH NURSE (B)(6), RESPONSIBLE FOR THE TECHNICAL AREA OF THE HOSPITAL'S MATERIALS CENTER. IT IS A MATERIAL THAT HAS POROSITY DUE TO EXPOSURE TO THE TEMPERATURE OF THE STERILIZATION PROCESS. IT IS THE POROSITY OF THE CELERON THAT COMPROMISES THE CLEANING PROCESS. IT WAS UNDERSTOOD THEN THAT THE MATERIAL COMPROMISES THE STERILIZATION PROCESS, SINCE IT HAS POROSITY THAT DOES NOT GUARANTEE THE EFFECTIVENESS OF CLEANING. IF YOU ARE NOT IN ACCORDANCE WITH THE JUSTIFICATION PRESENTED, I SUGGEST THAT YOU PRESENT TO THE HOSPITAL TECHNICIANS RESPONSIBLE, A DOCUMENT WITH THE MANUFACTURER'S SPECIFICATIONS THAT MEET THE STANDARDS OF THE MANUALS OF GOOD CLEANING AND STERILIZATION PRACTICES. THIS REPORT IS FOR ONE (1) STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM. THIS IS REPORT 3 OF 15 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863312 ↗
• MalfunctionSep 27, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT A CUSTOMER NOTIFIED US THAT THEY HAVE A COUPLE OF BROKEN SYNTHES INSTRUMENTS. BALL SPIKE, STRAIGHT: REASON: SPIKE TIP BROKEN OFF, P/N: 03.100.018, S/N: (B)(4). T-HANDLE, QUICK COUPLING: REASON: COUPLING SLEEVE STUCK, CANNOT GRAB ONTO TAP, P/N: 311.44, S/N: (B)(4). THIS REPORT IS FOR ONE (1) BALL SPIK STRAIG 6.5 L300. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131557 ↗
• MalfunctionMay 30, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM WAS BROKEN/BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8656043 ↗