Biosyn SM-5678Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521033092), received between Oct 10, 2019 and Sep 1, 2022 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).

28 other recalls cover devices cleared under the same FDA submission (K000037); they may or may not involve this specific model.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A REMOVAL OF THE BREAST QUADRANT WITH THE AXILLARY NODE, THE THREAD OF THE TWO DEVICES BROKE. TO RESOLVE THE ISSUE, A NEW PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15340189 ↗
• MalfunctionJul 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN ORTHOPEDIC SURGERY, AT SKIN CLOSURE, FOUR SUTURES HAD NEEDLES FELL OFF THEIR THREADS AT THE SWAGE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14893036 ↗
• MalfunctionJul 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN ORTHOPEDIC SURGERY, AT SKIN CLOSURE, FOUR SUTURES HAD NEEDLES FELL OFF THEIR THREADS AT THE SWAGE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14892916 ↗
• MalfunctionJul 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN ORTHOPEDIC SURGERY, AT SKIN CLOSURE, FOUR SUTURES HAD NEEDLES FELL OFF THEIR THREADS AT THE SWAGE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14892895 ↗
• MalfunctionJul 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN ORTHOPEDIC SURGERY, AT SKIN CLOSURE, FOUR SUTURES HAD NEEDLES FELL OFF THEIR THREADS AT THE SWAGE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14892791 ↗
• MalfunctionMar 10, 2022Break; Break

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC PROCEDURE WHILE CLOSING THE PORT SITE, THE THREAD BROKE. ANOTHER SUTURE WAS OPENED BUT IT BROKE AS WELL. A COMPETITOR'S PRODUCT WAS INSTEAD OPENED TO COMPLETE THE CASE. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13724822 ↗
• InjuryFeb 25, 2021Break; Break

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A RIGHT FEMORAL-BELOW KNEE POPLITEAL ARTERY BYPASS WITH POLYTETRAFLUOROETHYLENE GRAFT, TWO SUTURE BREAKAGES WERE REPORTED BY SURGICAL FIRST ASSISTANTS DURING ROUTINE SUB CUTANEOUS WOUND CLOSURE TREATED WITH WET-DRY DRESSING CHANGE. THE PATIENT WAS READMITTED AFTER 13 DAYS, WITH PSEUDOMONAS SEPTICEMIA OF UNKNOWN SOURCE, GRAFT INFECTION. A SIX-WEEK COURSE OF INTRAVENOUS ANTIBIOTICS WAS PROVIDED AND FOLLOWUP IN THE CLINIC.

  Patient problems: Post Operative Wound Infection; Sepsis; Unspecified Tissue Injury

  MAUDE report 11378310 ↗
• MalfunctionMar 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING TOTAL HYSTERECTOMY PROCEDURE, WHILE USING RUNNING STITCH TO CLOSE THE SKIN, THE SUTURE POPPED OFF THE NEEDLE. THIS HAPPENED TWICE. A THIRD SUTURE WAS OPENED AND USED WITH NO ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9896533 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A MONTH FOLLOWING AN OPEN HIP REPLACEMENT ARTHROPLASTY, IT WAS STATED THAT ON THE 2ND OF MAY, PATIENT WAS PRESENTED WITH DRAINING HEMATOMA. A REVISION OF RIGHT HIP WITH IRRIGATION DEBRIDEMENT BALL AND LINER EXCHANGE PERFORMED TO CORRECT THE ISSUE.

  Patient problems: Hematoma; No Code Available

  MAUDE report 9547974 ↗
• InjuryJan 3, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE REPLACEMENT ARTHROPLASTY, THE PATIENT PRESENTED WITH DEHISCENCE ON LEFT KNEE FOLLOWING A FALL. INCISION AND DRAINAGE WAS REQUIRED TO RESOLVE THE ISSUE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9546950 ↗
• MalfunctionNov 8, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S NEEDLE AND THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9295186 ↗
• MalfunctionNov 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A WOUND CLOSURE OF AN OPEN PROCEDURE, THE NEEDLE BROKE ON FIRST SUTURE BUT THE SURGEON CONTINUED TO USE IT. ABOUT HALF WAY THROUGH, THE NEEDLE SNAPPED RIGHT OFF THE END OF THE THREAD ON THE SECOND SUTURE. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9295126 ↗
• MalfunctionOct 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN C-SECTION PROCEDURE, THE DEVICE, NEEDLE POPPED OFF FROM THE THREAD WHILE THE SURGEON PERFORMING A RUNNING STITCH. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9177726 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000037. One submission often covers many models, so check the product and lot details in each record.

• Z-1291-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but n
• Z-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• Z-1295-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• Z-1282-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1286-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1290-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1289-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1297-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1287-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1285-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1284-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1294-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• Z-1293-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no
• Z-1292-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, bu
• Z-1276-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not

…and 13 more.