NA 03.100.120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982071170), received between May 5, 2021 and Mar 31, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INTRAOPERATIVE USE, THE SPIKED ROUND DISK DISCONNECTED FROM THE BALL SPIKE ANGLED 30° PNTD BALL TIPS 6.5 WHILE ACTIVELY BEING USED ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24747262 ↗
• MalfunctionMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPIKED DISC ROUND-HO 6.5 DISCONNECTED FROM THE BALL SPIKE ANGLED 30° PNTD BALL TIPS 6.5 WHILE INSIDE THE PATIENT, RESULTING IN A DELAY IN SURGERY AND POTENTIAL DISRUPTION TO SURROUNDING TISSUE DURING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746921 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  THE SPIKED ROUND DISK DISCONNECTED FROM THE BALL SPIKE ANGLED 30° PNTD BALL TIPS 6.5 WHILE ACTIVELY BEING USED ON A PATIENT. THE BALL SPIKE ANGLED 15° PNTD BALL TIPS 6.5 WAS IDENTIFIED AS THE INSTRUMENT OF CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719231 ↗
• InjuryMay 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN ACETABULAR RECONSTRUCTION PROCEDURE, THE BALL SPIKE PUSHER WAS USED, WITH A ROUND SPIKED DISC. WHEN THE BALL SPIKE WAS WITHDRAWN, IT BECAME DISCONNECTED FROM THE DISC, WHICH REMAINED IN THE PATIENT. ATTEMPTS WERE MADE FOR SIXTY (60) MINUTES TO RETRIEVE THE DISC, AFTER WHICH A CLINICAL DECISION WAS MADE TO LEAVE IT IN SITU. THIS REPORT INVOLVES ONE (1) SPIKED ROUND DISK. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11778540 ↗