DYNATAPE 280825Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20886705031198), received between May 4, 2022 and Feb 6, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Unintended Movement; Unintended Movement

  THIS IS REPORT 2 OF 6 FOR (B)(4). IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT (TSA) SURGICAL PROCEDURE WHILE USING 6X DYNATAPE DEVICES THE SURGEON HAD MULTIPLE FAILED LESSER TUBEROSITY OSTEOTOMIES (LTO) DURING HIS PROCEDURES RECENTLY AND DECIDED TO DO A REVISION ON THE PATIENT. HE PERFORMED A REVISION ON THE PATIENT AND FOUND THAT TWO BROKEN DYNATAPE DEVICES AND FOUR DYNATAPE DEVICES CAME UNTIED. IT WAS UNKNOWN IF ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WERE ANY DELAYS IN THE PROCEDURE. THERE WAS MEDICAL INTERVENTION WHERE A REVISION TSA WAS PERFORMED. THERE WAS PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21326858 ↗
• InjuryFeb 6, 2025Break; Break

  THIS IS REPORT 3 OF 6 FOR (B)(4). IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT (TSA) SURGICAL PROCEDURE WHILE USING 6X DYNATAPE DEVICES THE SURGEON HAD MULTIPLE FAILED LESSER TUBEROSITY OSTEOTOMIES (LTO) DURING HIS PROCEDURES RECENTLY AND DECIDED TO DO A REVISION ON THE PATIENT. HE PERFORMED A REVISION ON THE PATIENT AND FOUND THAT TWO BROKEN DYNATAPE DEVICES AND FOUR DYNATAPE DEVICES CAME UNTIED. IT WAS UNKNOWN IF ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WERE ANY DELAYS IN THE PROCEDURE. THERE WAS MEDICAL INTERVENTION WHERE A REVISION TSA WAS PERFORMED. THERE WAS PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21326857 ↗
• InjuryFeb 6, 2025Break; Break

  THIS IS REPORT 1 OF 6 FOR (B)(4). IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT (TSA) SURGICAL PROCEDURE WHILE USING 6X DYNATAPE DEVICES THE SURGEON HAD MULTIPLE FAILED LESSER TUBEROSITY OSTEOTOMIES (LTO) DURING HIS PROCEDURES RECENTLY AND DECIDED TO DO A REVISION ON THE PATIENT. HE PERFORMED A REVISION ON THE PATIENT AND FOUND THAT TWO BROKEN DYNATAPE DEVICES AND FOUR DYNATAPE DEVICES CAME UNTIED. IT WAS UNKNOWN IF ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WERE ANY DELAYS IN THE PROCEDURE. THERE WAS MEDICAL INTERVENTION WHERE A REVISION TSA WAS PERFORMED. THERE WAS PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21326845 ↗
• InjuryFeb 6, 2025Break; Unintended Movement; Break; Unintended Movement

  THIS IS REPORT 3 OF 6 FOR (B)(4). IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE, IT WAS DISCOVERED THAT SIX DYNATAPE DEVICES FAILED DURING THE LESSER TUBEROSITY OSTEOTOMY (LTO). ACCORDING TO THE REPORTER, THE SURGEON CONSISTENTLY USED SIX DYNATAPES PER TOTAL SHOULDER ARTHROPLASTY (TSA). IT WAS REPORTED THAT THE TREATMENT FAILURE WAS CONFIRMED THROUGH IN-CLINIC TESTING, MRI, AND REVISION SURGERY. A REVISION PROCEDURE WAS PERFORMED, BUT THE PATIENT¿S CURRENT CONDITION REMAINS UNCLEAR. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE REPORTS OF MEDICAL INTERVENTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21324430 ↗
• InjuryFeb 6, 2025Break; Unintended Movement; Break; Unintended Movement

  THIS IS REPORT 2 OF 6 FOR (B)(4). IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE, IT WAS DISCOVERED THAT SIX DYNATAPE DEVICES FAILED DURING THE LESSER TUBEROSITY OSTEOTOMY (LTO). ACCORDING TO THE REPORTER, THE SURGEON CONSISTENTLY USED SIX DYNATAPES PER TOTAL SHOULDER ARTHROPLASTY (TSA). IT WAS REPORTED THAT THE TREATMENT FAILURE WAS CONFIRMED THROUGH IN-CLINIC TESTING, MRI, AND REVISION SURGERY. A REVISION PROCEDURE WAS PERFORMED, BUT THE PATIENT¿S CURRENT CONDITION REMAINS UNCLEAR. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE REPORTS OF MEDICAL INTERVENTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21324426 ↗
• InjuryFeb 6, 2025Break; Unintended Movement; Break; Unintended Movement

  THIS IS REPORT 1 OF 6 FOR (B)(4). IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE, IT WAS DISCOVERED THAT SIX DYNATAPE DEVICES FAILED DURING THE LESSER TUBEROSITY OSTEOTOMY (LTO). ACCORDING TO THE REPORTER, THE SURGEON CONSISTENTLY USED SIX DYNATAPES PER TOTAL SHOULDER ARTHROPLASTY (TSA). IT WAS REPORTED THAT THE TREATMENT FAILURE WAS CONFIRMED THROUGH IN-CLINIC TESTING, MRI, AND REVISION SURGERY. A REVISION PROCEDURE WAS PERFORMED, BUT THE PATIENT¿S CURRENT CONDITION REMAINS UNCLEAR. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE REPORTS OF MEDICAL INTERVENTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21324422 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH THE CLINICAL RESEARCH TEAM THAT DURING A ROTATOR CUFF REPAIR PROCEDURE OF THE RIGHT SHOULDER ON (B)(6) 2023, A DYNATAPE SUTURE WHITE/BLACK BRAIDED FLAT SUTURE 2.5MM 36 INCH (91CM) DEVICE WAS USED. ACCORDING TO THE REPORT, POSTOPERATIVELY ON (B)(6) 2023, THE PATIENT HAD RE-TEARS/NEW TEARS THAT RESULTED IN A RE-OPERATION/REVISION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16964473 ↗
• MalfunctionMay 4, 2022Crack; Crack

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE OF THE DYNATAPETM SUTURE, WHITE/BLACK BRAIDED FLAT SUTURE, 6/PACK WAS FRAYED AND THE NEEDLE WITH STAINLESS STEEL WIRE LOOP, 12 PK BROKE. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14280977 ↗