NA 394.951Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034777399), received between Oct 2, 2019 and Oct 2, 2019 — classified as 9 malfunctions.

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.

• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER (B)(6) 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR ONE (1) QUICK RELEASE T-HANDLE. THIS IS REPORT 8 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144945 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER JULY 17, 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON SEPTEMBER 5, 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR ONE (1) QUICK RELEASE T-HANDLE. THIS IS REPORT 7 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144943 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER JULY 17, 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON SEPTEMBER 5, 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR ONE (1) QUICK RELEASE T-HANDLE. THIS IS REPORT 5 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144940 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER (B)(6) 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR ONE (1) QUICK RELEASE T-HANDLE THIS IS REPORT 6 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144936 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER JULY 17, 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON SEPTEMBER 5, 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR ONE (1) QUICK RELEASE T-HANDLE. THIS IS REPORT 4 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144935 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER (B)(6) 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES TWENTY-ONE (21) DEVICES. THIS REPORT IS FOR ONE (1) QUICK RELEASE T-HANDLE. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144654 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER JULY 17, 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON SEPTEMBER 5, 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES TWENTY-ONE (21) DEVICES. THIS REPORT IS FOR ONE (1) QUICK RELEASE T-HANDLE. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144649 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER (B)(6) 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES TWENTY-ONE (21) DEVICES. THIS REPORT IS FOR ONE (1) QUICK RELEASE T-HANDLE. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144645 ↗
• MalfunctionOct 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER JULY 17, 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON SEPTEMBER 5, 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES TWENTY-ONE (21) DEVICES. THIS REPORT IS FOR ONE (1) QUICK RELEASE T-HANDLE. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144638 ↗