Speed Arc SE-111210ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810633021415), received between Jan 10, 2019 and Nov 12, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SPEEDARC COMPRESSION INPLANT KIT STAPLE WAS DISCOVERED AS NOT CENTERED OR STRAIGHT ON INSERTION HANDLE. PRODUCT WAS NOT USED OR OPENED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SPEEDARC COMPRESSION IMPL KIT 11X12X10. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804580 ↗
• MalfunctionNov 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SPPEEDARC COMPRESSION INPLANT KIT STAPLE WAS DISCOVERED AS NOT CENTERED OR STRAIGHT ON INSERTION HANDLE. PRODUCT WAS NOT USED OR OPENED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SPEEDARC COMPRESSION IMPL KIT 11X12X10. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804562 ↗
• MalfunctionNov 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SPEEDARC COMPRESSION IMPLANT KIT INSERTION HANDLE WAS MISALIGNED. THE STAPLE WAS LOADED OFF CENTER. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) SPEEDARC COMPRESSION IMPL KIT 11X12X10. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779020 ↗
• MalfunctionFeb 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021, THE STAPLE FELL OFF THE INSERTER. OPENED ANOTHER STAPLE. THERE WAS A SURGICAL DELAY OF TWO MINUTES. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SPEEDARC(TM) IMPLANT KIT 11 X 12 X 10 MM. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300247 ↗
• MalfunctionJan 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  CONCOMITANT DEVICE REPORTED: UNK - HANDLES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235064 ↗