The Tether™ 230H4001Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00887868227431), received between Apr 20, 2021 and Aug 25, 2025 — classified as 8 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Fracture” (24 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE FINALIZING THE SECURING OF THE CORD WITH THE SET SCREW, THE SCREW FAILED TO ENGAGE WITH THE DRIVER; THE DRIVER WAS STRIPPED. A SECOND DRIVER WAS ALSO FOUND TO BE STRIPPED. THE SURGERY WAS COMPLETED USING A THIRD DRIVER WITH NO PATIENT HARM AND ONLY A TWO MINUTE PROCEDURAL DELAY. UPON MANUFACTURER INVESTIGATION, IT WAS DISCOVERED THAT BOTH TETHER DRIVERS HAD FRACTURED TIPS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890200 ↗
• MalfunctionAug 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE FINALIZING THE SECURING OF THE CORD WITH THE SET SCREW, THE SCREW FAILED TO ENGAGE WITH THE DRIVER; THE DRIVER WAS STRIPPED. A SECOND DRIVER WAS ALSO FOUND TO BE STRIPPED. THE SURGERY WAS COMPLETED USING A THIRD DRIVER WITH NO PATIENT HARM AND ONLY A TWO MINUTE PROCEDURAL DELAY. UPON MANUFACTURER INVESTIGATION, IT WAS DISCOVERED THAT BOTH TETHER DRIVERS HAD FRACTURED TIPS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890194 ↗
• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO TETHER SET SCREW DRIVER TIPS FRACTURED DURING A SURGERY. THE C-RINGS BROKE OFF IN THE TULIP HEAD OF THE TETHER SCREWS. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30-45 MINUTE DELAY TO RETRIEVE THE BROKEN PIECES. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874467 ↗
• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO TETHER SET SCREW DRIVER TIPS FRACTURED DURING A SURGERY. THE C-RINGS BROKE OFF IN THE TULIP HEAD OF THE TETHER SCREWS. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30-45 MINUTE DELAY TO RETRIEVE THE BROKEN PIECES. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874455 ↗
• MalfunctionJun 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A STRIPPED TETHER SET SCREW DRIVER WAS FOUND DURING A SURGERY AFTER THE DRIVER FAILED TO ENGAGE THE SET SCREW WHILE SECURING THE CORD. THE SURGERY WAS COMPLETED WITH A SECOND DRIVER WITHOUT ANY PROCEDURAL DELAY OR PATIENT IMPACT. UPON MANUFACTURER INVESTIGATION, IT WAS DISCOVERED THAT THE TIP OF THE DRIVER WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328779 ↗
• InjurySep 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE FINAL TIGHTENING OF THE SET SCREW, THE DRIVER'S TIP BROKE OFF, GETTING STUCK IN THE SET SCREW AND CAUSING IT TO BE RETAINED IN THE PATIENT. THERE WAS NO OTHER PATIENT IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17807815 ↗
• MalfunctionMay 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TWO FINAL DRIVERS WOULD NOT RETAIN THE MATING SET SCREWS INTRA-OPERATIVELY. THERE WERE NO IMPACTS TO THE PATIENT. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THAT THE TIPS HAD FRACTURED OFF BOTH DRIVERS.THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035107 ↗
• MalfunctionMay 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TWO FINAL DRIVERS WOULD NOT RETAIN THE MATING SET SCREWS INTRA-OPERATIVELY. THERE WERE NO IMPACTS TO THE PATIENT. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THAT THE TIPS HAD FRACTURED OFF BOTH DRIVERS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17034880 ↗
• InjuryDec 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO TETHER SET SCREW DRIVERS FRACTURED DURING SURGERY. ONE DRIVER TIP FRACTURED OFF COMPLETELY IN THE SET SCREW AND REMAINED IMPLANTED IN THE PATIENT, THE OTHER FRACTURED INCOMPLETELY AND WAS RETRIEVED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16023546 ↗
• MalfunctionDec 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO TETHER SET SCREW DRIVERS FRACTURED DURING SURGERY. ONE DRIVER TIP FRACTURED OFF COMPLETELY IN THE SET SCREW AND REMAINED IMPLANTED IN THE PATIENT, THE OTHER FRACTURED INCOMPLETELY AND WAS RETRIEVED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023544 ↗
• MalfunctionDec 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS FINAL TIGHTENING A SET SCREW WHEN THE TIP OF THE SET SCREW DRIVER BROKE OFF INSIDE OF THE ANCHOR. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN DRIVER TIP WITHOUT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914837 ↗
• MalfunctionNov 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SET SCREW FELL OFF THE TETHER SET SCREW DRIVER INTRA-OPERATIVELY; THE TIP HAD FRACTURED OFF. THE OTHER SET SCREW DRIVER IN THE SET WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831067 ↗
• InjuryAug 5, 2022Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT A TETHER SET SCREW DRIVER JAMMED IN THE COUNTER TENSIONER AND WAS DIFFICULT TO DETACH FROM THE SET SCREW INTRAOPERATIVELY. WHILE CLEANING THE DRIVER AT THE END OF THE PROCEDURE, THE TIP WAS FOUND TO HAVE FRACTURED OFF AND IS PRESUMED TO BE RETAINED WITHIN THE SET SCREW. THERE HAVE NOT BEEN ANY REPORTED PATIENT IMPACTS ASSOCIATED WITH THE RETAINED FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15178638 ↗
• MalfunctionJul 29, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TIP OF A SET SCREW DRIVER WAS FOUND TO BE WORN DOWN DURING AN INSPECTION. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THE DRIVE TIP HAD FRACTURED OFF. THE SPECIFIC PATIENT AND SURGICAL INFORMATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15130388 ↗
• MalfunctionJul 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT 3 TETHER SET SCREW DRIVERS WITH FRACTURED TIPS WERE RECEIVED AT A WAREHOUSE FROM A HOSPITAL. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR SURGICAL INFORMATION WITH THE RETURNED PARTS. THE SALES REP FOR THE HOSPITAL WAS CONTACTED AND CONFIRMED THERE WERE NO PATIENT IMPACTS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032474 ↗
• MalfunctionJul 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT 3 TETHER SET SCREW DRIVERS WITH FRACTURED TIPS WERE RECEIVED AT A WAREHOUSE FROM A HOSPITAL. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR SURGICAL INFORMATION WITH THE RETURNED PARTS. THE SALES REP FOR THE HOSPITAL WAS CONTACTED AND CONFIRMED THERE WERE NO PATIENT IMPACTS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032333 ↗
• MalfunctionJul 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT 3 TETHER SET SCREW DRIVERS WITH FRACTURED TIPS WERE RECEIVED AT A WAREHOUSE FROM A HOSPITAL. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR SURGICAL INFORMATION WITH THE RETURNED PARTS. THE SALES REP FOR THE HOSPITAL WAS CONTACTED AND CONFIRMED THERE WERE NO PATIENT IMPACTS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032325 ↗
• InjuryJun 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A TETHER SET SCREW DRIVER FRACTURED INTRA-OPERATIVELY. IT WAS STUCK IN THE SET SCREW AND THE SURGEON ELECTED NOT TO REMOVE IT. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14732941 ↗
• InjuryMay 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A SET SCREW DRIVER BROKE OFF INTO ITS MATING SET SCREW DURING FINAL TIGHTENING OF A TETHER CONSTRUCT INTRA-OPERATIVELY. THE SURGEON ELECTED TO LEAVE THE DRIVER TIP IN ITS MATING SET SCREW. THERE WERE NO IMMEDIATE PATIENT IMPACTS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14517824 ↗
• MalfunctionMay 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS WERE FOUND TO BE DAMAGED DURING A ROUTINE INSPECTION. NO SPECIFIC PATIENT OR SURGICAL INFORMATION IS KNOWN. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 14463510 ↗
• MalfunctionMay 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, A SET SCREWDRIVER TIP GOT STUCK IN ONE OF THE SET SCREWS. UPON REMOVAL OF THE DRIVER, THE TIP BROKE OFF IN THE SET SCREW. THE BROKEN TIP WAS REMOVED. THERE WAS A SHORT DELAY AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408547 ↗
• MalfunctionFeb 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE TETHER SET SCREW DRIVER BROKE OFF INTRA-OPERATIVELY DURING TIGHTENING. THE FRACTURED PIECE WAS RECOVERED USING A CURETTE, AND THE SURGERY WAS COMPLETED USING THE SECOND DRIVER IN THE KIT. THERE WAS NO DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559554 ↗
• MalfunctionFeb 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A SET SCREWDRIVER SHEARED OFF DURING FINAL TIGHTENING. ANOTHER DRIVER WAS USED TO COMPLETE THE CASE. NO HARM CAME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509526 ↗
• MalfunctionDec 31, 2021Fracture; Fracture

  IT WAS REPORTED THE TIP OF A TETHER SET SCREW DRIVER BROKE OFF INTRA-OPERATIVELY. THE TIP WAS RECOVERED WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13125436 ↗
• MalfunctionNov 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SCREW DRIVER WAS WORN. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THAT THE TIP HAD FRACTURED OFF. THE ASSOCIATED PATIENT AND SURGICAL INFORMATION AT THE TIME OF THE FRACTURE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12801616 ↗