TRUEPASS 72203793Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00885554030433), received between Aug 16, 2017 and Feb 10, 2026 — classified as 22 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (37 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER ARTHROSCOPY FOR ROTATOR CUFF REPAIR, A TRUEPASS NEEDLE BROKE, USED WITH TRUEPASS FORCEPS. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING ARTHROSCOPY. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306370 ↗
• MalfunctionFeb 10, 2026Break

  WITH TRUEPASS FORCEPS. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING ARTHROSCOPY. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306355 ↗
• InjuryJul 9, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A SHOULDER LIGAMENT REPAIR SURGERY, THE TRUEPASS NEEDLE HAD A BREAK. IT BROKE IN THE PATIENT, AND COULD NOT BE FOUND. SURGERY WAS COMPLETED WITH THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY, BUT NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22465561 ↗
• InjuryJul 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER TENDON REPAIR SURGERY, THE TRUEPASS NEEDLE HAD A BREAK. IT BROKE IN THE PATIENT, AND COULD NOT BE FOUND, BUT WAS LEFT SECURED. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 22465538 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN PASSING THE TRUE PASS NEEDLE CLAMP, THE DOCTOR NOTICED THAT THE TIP OF THE DEVICE WAS BROKEN INSIDE THE PACKAGING. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711971 ↗
• InjuryAug 1, 2023Break; Break

  IT WAS REPORTED THAT AFTER A ROTATOR CUFF REPAIR, IT WAS CONFIRMED THAT THE TIP OF THE TRUEPASS NEEDLE SNAPPED AND WAS LEFT INSIDE THE PATIENT. THE BROKEN TIP WAS REMOVED FROM PATIENT VIA REVISION SURGERY. A DELAY OF 1 HOUR WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438435 ↗
• InjuryJul 27, 2023Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER REPAIR SURGERY, THE TRUE PASS NEEDLE BROKE. THE BROKEN PART WAS CAREFULLY SEARCHED, HOWEVER, IT COULD NOT BE FOUND. THE SIZE OF THE BROKEN PART WAS ABOUT 2MM. SINCE THE SURGEON DID NOT FIND THE BROKEN PART, THE PATIENT WAS STITCHED UP AND THE PROCEDURE WAS COMPLETED, HOWEVER, IT IS UNKNOWN IF THERE WAS ANY DELAY. AFTER SURGERY, THROUGH A CB MACHINE FLUOROSCOPY, IT WAS CONFIRMED THAT THE CARTRIDGE FOR THE TRUEPASS SUTURE CLAMP WAS LEFT INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT WAS DISCHARGED SMOOTHLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17410120 ↗
• MalfunctionJun 23, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE TRUEPASS BROKE OFF IN PATIENT'S KNEE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192302 ↗
• InjuryDec 1, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR USING A TRUEPASS DISPOSABLE NEEDLE, AFTER PASSING 2 SUTURES, IT WAS NOT POSSIBLE TO PASS ANOTHER SUTURE. UPON EXAMINATION OF THE NEEDLE, IT WAS NOTICED THE TIP WAS BROKEN. THE NEEDLE TIP COULD NOT BE SEEN. THE JOINT WAS FLUSHED WITH SALINE AND SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15899455 ↗
• InjuryMay 4, 2022Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE TRUEPASS NEEDLE BROKE WHEN PASSING THE SUTURE. THE TIP OF THE NEEDLE WAS LOST INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14279477 ↗
• InjuryMar 14, 2022Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE, THE TRUE PASS NEEDLE BROKE. THE BROKEN PIECE WAS RETRIEVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757191 ↗
• InjuryNov 8, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TRUEPASS NEEDLE BROKE OFF IN THE PATIENT'S SHOULDER. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771317 ↗
• InjuryOct 10, 2021Break; Break

  IT WAS REPORTED THAT DURING SHOULDER SURGERY, THE TRUEPASS NEEDLE BROKE INSIDE OF THE PATIENT. THE FRAGMENTS THAT BROKE OFF ARE LOST IN THE PATIENT'S SHOULDER BUT VISIBLE ON X-RAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACKUP DEVICE. THE PATIENT IS REPORTED TO HAVE RESIDUAL PAIN.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 12603028 ↗
• InjuryOct 10, 2021Break; Break

  IT WAS REPORTED THAT DURING SHOULDER SURGERY, THE TRUEPASS NEEDLE BROKE INSIDE OF THE PATIENT. THE FRAGMENTS THAT BROKE OFF ARE LOST IN THE PATIENT'S SHOULDER BUT VISIBLE ON X-RAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACKUP DEVICE. THE PATIENT IS REPORTED TO HAVE RESIDUAL PAIN.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 12603027 ↗
• InjurySep 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE TRUEPASS NEEDLE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A BACKUP AVAILABLE. NO DELAY, AND NO FURTHER COMPLICATIONS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467174 ↗
• InjurySep 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE TRUEPASS NEEDLE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A BACKUP AVAILABLE. NO DELAY, AND NO FURTHER COMPLICATIONS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467160 ↗
• MalfunctionMay 24, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, THE FINAL PART OF THE NAIL (2 MM) REMAINED STUCK IN THE SHOULDER BLADE AND COULD NOT BE DIGGED OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. ADDITIONALLY, AN UNSPECIFIED INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872728 ↗
• InjuryApr 28, 2021Break; Break

  IT WAS REPORTED THAT DURING SHOULDER ROTATOR CUFF REPAIR SURGERY USING A TRUEPASS NEEDLE, THE NEEDLE WAS BROKEN. THE PROCEDURE WAS FINISHED WITH A CHANGE IN SURGICAL TECHNIQUE. NO SIGNIFICANT DELAY AND NO OTHER COMPLICATIONS WERE REPORTED. ADDITIONALLY, NO PIECES WERE FOUND IN X-RAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737007 ↗
• InjuryApr 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ROTATOR CUFF REPAIR SURGERY, THE TRUEPASS NEEDLE WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 30 MINUTES OR LESS USING A BACK-UP DEVICE. IT WAS NOT POSSIBLE TO REMOVE THE BROKEN NEEDLE FROM WITHIN THE PATIENT. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11616895 ↗
• MalfunctionMar 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY USING A "TRUEPASS NEEDLE", WHEN PASSING THE NEEDLE WITH THE TRUEPASS FORCEPS THROUGH THE TENDON OF THE CUFF, THE 2 TIPS OF THE NEEDLE HAVE BEEN BROKEN IN THE DISTAL PART. THE NEEDLE TIP WAS EXTRACTED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS FINE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580104 ↗
• MalfunctionMar 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY USING A "TRUEPASS NEEDLE", WHEN PASSING THE NEEDLE WITH THE TRUEPASS FORCEPS THROUGH THE TENDON OF THE CUFF, THE 2 TIPS OF THE NEEDLE HAVE BEEN BROKEN IN THE DISTAL PART. THE NEEDLE TIP REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS FINE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11580102 ↗
• InjuryJan 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR SURGERY THE NEEDLE OF THE TRUEPASS BROKE INSIDE THE PATIENT AND PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11174212 ↗
• InjuryDec 15, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE FIRST "TRUEPASS" NEEDLE PASSED THROUGH THE ROTATOR CUFF, AND THE THREAD WAS BROUGHT OUT. THE NURSE CHECKED THAT THE NEEDLE WAS COMPLETE, BUT THE THREAD FAILED TO PENETRATE THE ROTATOR CUFF DURING THE SECOND NEEDLE, AND THE NEEDLE WAS BROKEN. THE BROKEN NEEDLE WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING INCISION AND NEEDLE SUTURE TECHNIQUE. THE PATIENT WAS DISCHARGED FROM HOSPITAL AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11007389 ↗
• InjuryNov 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY AND CUFF REPAIR PROCEDURE, THE TRUEPASS NEEDLES BROKE INSIDE THE PATIENT. THE BROKEN PIECES COULD NOT BE RETRIEVED BUT THE JOINT WAS WASHED WITH SALINE AND SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A FIRSTPASS. NO COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10808178 ↗
• InjuryNov 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY AND CUFF REPAIR PROCEDURE, THE TRUEPASS NEEDLES BROKE INSIDE THE PATIENT. THE BROKEN PIECES COULD NOT BE RETRIEVED BUT THE JOINT WAS WASHED WITH SALINE AND SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A FIRSTPASS. NO COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10808176 ↗