PDS Z397HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031060838), received between Aug 19, 2019 and May 2, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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.

• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON REPAIR FOR WITH EXTENSOR SUTURE ON FINGER WOUND ON (B)(6) 2025 AND SUTURE WAS USED. THE IMMEDIATE POSTOPERATIVE OUTCOME WAS GOOD, BUT AFTER ONE MONTH, SIGNIFICANT SCAR-RELATED INFLAMMATION WAS OBSERVED, AND AFTER TWO MONTHS, THERE WAS REJECTION OF THE SUTURE ALONG WITH DEHISCENCE. ALCOHOLIC BETADINE WAS USED DURING THE SCRUBBING PROCESS. AT ONE AND HALF MONTHS POST-OP, THERE WAS THREAD REJECTION AT THE SKIN. THE PATIENT UNDERWENT SURGICAL REVISION ON (B)(6) 2025 AND EXTRACTED SUTURE FROM THE PATIENT'S SKIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Local Reaction; Pocket Erosion; Wound Dehiscence

  MAUDE report 21951355 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON REPAIR FOR WITH EXTENSOR SUTURE ON IPD ARTHRODESIS ON (B)(6) 2025 AND SUTURE WAS USED. THE IMMEDIATE POSTOPERATIVE OUTCOME WAS GOOD, BUT AFTER ONE MONTH, SIGNIFICANT SCAR-RELATED INFLAMMATION WAS OBSERVED, AND AFTER TWO MONTHS, THERE WAS REJECTION OF THE SUTURE ALONG WITH DEHISCENCE. ALCOHOLIC BETADINE WAS USED DURING THE SCRUBBING PROCESS. THE PATIENT HAD SCAR SENSITIVITY FOR A LONG TIME AND REAL PAIN AFTER 2 MONTHS THE PATIENT UNDERWENT SURGICAL REVISION ON (B)(6) 2025. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Local Reaction; Pain; Wound Dehiscence

  MAUDE report 21951351 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON REPAIR FOR WITH EXTENSOR SUTURE ON RIGHT LITTLE FINGER IPP ARTHRODESIS ON (B)(6) 2025 AND SUTURE WAS USED. THE IMMEDIATE POSTOPERATIVE OUTCOME WAS GOOD, BUT AFTER ONE MONTH, SIGNIFICANT SCAR-RELATED INFLAMMATION WAS OBSERVED, AND AFTER TWO MONTHS, THERE WAS REJECTION OF THE SUTURE ALONG WITH DEHISCENCE. ALCOHOLIC BETADINE WAS USED DURING THE SCRUBBING PROCESS. AT ONE AND HALF MONTHS POST-OP, THERE WAS THREAD REJECTION AT THE SKIN. THE PATIENT UNDERWENT SURGICAL REVISION ON (B)(6) 2025 AND EXTRACTED SUTURE FROM THE PATIENT'S SKIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Local Reaction; Wound Dehiscence

  MAUDE report 21951309 ↗
• MalfunctionJan 20, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A PROCEDURE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11203490 ↗
• MalfunctionAug 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLES CAME OFF OF SUTURE DURING USE. IT IS UNKNOWN IF A SIMILAR DEVICE WAS USED OR IF IT WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907218 ↗
• MalfunctionAug 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLES CAME OFF OF SUTURE DURING USE. IT IS UNKNOWN IF A SIMILAR DEVICE WAS USED OR IF IT WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907213 ↗