DYNATAPE 280828Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20886705031181), received between Feb 6, 2025 and Feb 6, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Unintended Movement” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Unintended Movement; Unintended Movement

  THIS IS REPORT 6 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 21327377 ↗
• InjuryFeb 6, 2025Unintended Movement; Unintended Movement

  THIS IS REPORT 5 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 21327367 ↗
• InjuryFeb 6, 2025Unintended Movement; Unintended Movement

  THIS IS REPORT 4 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 21327346 ↗
• InjuryFeb 6, 2025Break; Unintended Movement; Break; Unintended Movement

  THIS IS REPORT 6 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 21327337 ↗
• InjuryFeb 6, 2025Break; Unintended Movement; Break; Unintended Movement

  THIS IS REPORT 5 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 21327330 ↗
• InjuryFeb 6, 2025Break; Unintended Movement; Break; Unintended Movement

  THIS IS REPORT 4 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 21327322 ↗