Stratafix Spiral SXPD1B401Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031227941), received between Apr 21, 2021 and Aug 5, 2026 — classified as 8 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50141449 ↗
• InjuryJun 10, 2026Break

  IT WAS REPORTED ON 8 JUNE 2026 THAT THE SUTURE BROKE INTRAOPERATIVELY. UNSPECIFIED SECONDARY SUTURE INJURIES WERE REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 25460977 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED ON (B)(6) 2026 THAT DURING A HYSTEROSCOPIC ENDOMETRIAL POLYPECTOMY CERVICAL CONE RESECTION SURGERY THE SUTURE BROKE INTRA-OP CAUSING THE PATIENT'S VAGINAL RESIDUAL END TO BLEED. THE PATIENT WAS IMMEDIATELY REPLACED WITH A NEW SUTURE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL INJURIES REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24756378 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED ON MARCH 6 2026 THAT DURING A HYSTEROSCOPIC ENDOMETRIAL POLYPECTOMY CERVICAL CONE RESECTION SURGERY THE SUTURE BROKE INTRA-OP CAUSING THE PATIENT'S VAGINAL RESIDUAL END TO BLEED. THE PATIENT WAS IMMEDIATELY REPLACED WITH A NEW SUTURE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL INJURIES REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24721396 ↗
• MalfunctionFeb 9, 2026Material Fragmentation

  IT WAS REPORTED ON (B)(6) 2026 THAT DURING A PROCEDURE THE NEEDLE BROKE. ALL THE PIECES WERE RETRIEVED. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291537 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025 THAT INTRA-OPERATIVELY A SUTURE BROKE, LEADING TO UTERUS BLEEDING. UTERINE HEMOSTASIS WAS ADMINISTERED AND THE SUTURE WAS REPLACED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23906860 ↗
• InjuryJul 17, 2025Separation Problem; Separation Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, THERE WAS A PROCEDURAL INTERVENTION TO RETRIEVE THE NEEDLE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535766 ↗
• InjuryJan 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED AFTER SUTURING, IT WAS FOUND THAT THE SUTURE KNOT HAD SLIPPED AND LOOSENED RESULTING IN INCOMPLETE ALIGNMENT OF THE OVARIAN TISSUE. A NEW SUTURE WAS NEEDED TO SUTURE THE OVARIAN RESULTING IN SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21072044 ↗
• InjuryNov 19, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2024 OUR DISTRIBUTOR REPORTED A PATIENT RETURNED TO THE DOCTOR THE DAY AFTER SURGERY TO HAVE THE STITCHES REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20723874 ↗
• InjuryNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  OUR DISTRIBUTOR IS REPORT THAT DURING UTERINE LEIOMYOMA THE NEEDLE BROKE AND FELL INTO THE PATIENT. A C-ARM WAS USED TO LOCATE AND RETRIEVE THE BROKEN NEEDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20631254 ↗
• InjuryMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  OUR DISTRIBUTOR REPORTED THE PATIENT WAS A 36-YEAR-OLD WOMAN WHO UNDERWENT LAPAROSCOPIC OVARIAN CYSTECTOMY IN HOSPITAL ON (B)(6) 2023. THE SURGEON USED SXPD1B401 FOR OVARIAN WOUND SEWING IN THE WAY OF CONTINUOUS SUTURING DURING THE SURGERY. THE SUTURE BROKE TWICE DURING SEWING. THE SURGEON IMMEDIATELY REPLACED A NEW ABSORBABLE SUTURE (WITH SPECIFIC PRODUCT INFORMATION UNKNOWN) FOR SEWING. THE SUBSEQUENT SURGERY WENT SMOOTHLY. AS A RESULT OF THIS EVENT, THE INTRAOPERATIVE BLOOD LOSS WAS INCREASED (THE SPECIFIC AMOUNT OF INCREASED BLOOD LOSS WAS UNKNOWN) AND THE OPERATION TIME WAS PROLONGED FOR ABOUT 15 MINUTES. THE PATIENT HAS BEEN SUCCESSFULLY DISCHARGED CURRENTLY. NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18926574 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTH AUTHORITY REPORTED TO OUR DISTRIBUTOR THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW SKIN DURING A SPINAL PROCEDURE. BESIDES, THE NEEDLE BROKE. THE DOCTOR REPLACED THE SUTURE WITH A NEW ONE AND CHECKED WHETHER THE BROKEN SUTURE WAS INTACT AND WHETHER IT WAS LEFT IN THE PATIENT''S BODY. ADDITIONAL DETAIL OF INTERVENTION OR DELAY COULD NOT BE OBTAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18913440 ↗
• MalfunctionJan 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING THE TISSUE. THE BROKEN NEEDLE FELL INTO THE PATIENT AND WAS RETRIEVED SHORTLY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT''S INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18449190 ↗
• MalfunctionNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT INJURY. THE BROKEN NEEDLE WAS RETRIEVED, THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18051780 ↗
• MalfunctionAug 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS CASE IS FROM HEALTH AUTHORITY. AT 16:15, THE PATIENT UNDERWENT SURGERY. DURING THE SURGERY, WHILE SUTURING THE OVARIES WITH SUTURE, THE NEEDLE SUDDENLY BROKE IN THE ABDOMINAL CAVITY. THE SURGEON IMMEDIATELY SEARCHED FOR THE BROKEN END OF THE NEEDLE AND FOUND THAT THE TAIL END OF THE BROKEN END WAS ON THE SURFACE OF THE OVARIES. THE BROKEN END WAS IMMEDIATELY REMOVED AND THE NEEDLE WAS INTACT . AFTERWARDS, ANOTHER SUTURE OF THE SAME TYPE WAS REPLACED TO SUTURE THE OVARIES. AFTER THE SURGERY, THE PATIENT''S VITAL SIGNS REMAINED STABLE AND PATIENT WAS SAFELY RETURNED TO THE WARD AFTER RESUSCITATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17611900 ↗
• InjuryFeb 2, 2023Break

  OUR DISTRIBUTOR REPORTED THE SUTURE BROKE WHEN SEWING IN A PROSTATE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION INDICATED THE PATIENT UNDERWENT LAPAROSCOPIC RADICAL PROSTATECTOMY. THE OPERATOR USED SXPD1B401 FOR WOUND SUTURING IN A CONTINUOUS MANNER (WITH SPECIFIC SUTURE TISSUE LEVEL UNKNOWN) DURING THE SURGERY. THE SUTURE BROKE DURING THE SUTURING. THE OPERATOR IMMEDIATELY REPLACED A NEW SUTURE (WITH SPECIFIC PRODUCT INFORMATION UNKNOWN) FOR SUTURING AGAIN. THE SUBSEQUENT OPERATION WENT SMOOTHLY. THIS EVENT LED TO WOUND OOZING (THE SPECIFIC AMOUNT OF OOZING WAS UNKNOWN). THE PATIENT WAS IN STABLE CONDITION CURRENTLY. NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 16282522 ↗
• MalfunctionSep 28, 2022Detachment of Device or Device Component; Device Fell

  ADDITIONAL INFORMATION AND PHOTOS WERE PROVIDED BY THE DISTRIBUTOR FOR A COMPLAINT INITIALLY REPORTED WITHOUT INCIDENT. IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE NEEDLE PULLING OFF THE SUTURE AND IT FELL INTO THE PATIENT. THE NEEDLE WAS EVENTUALLY LOCATED AND REMOVED INDICATING A DELAY IN SURGERY TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 15499788 ↗
• MalfunctionSep 8, 2022Break

  THIS CASE WAS REPORTED FROM THE HEALTH AUTHORITY TO OUR DISTRIBUTOR. AFTER THE MYOMA WAS REMOVED DURING THE SURGERY , THE NEEDLE TIP BROKE WHEN THE DOCTOR SEWED THE UTERINE WOUND. THROUGH REPEATED INSPECTION OF ABDOMINAL CAVITY AND PELVIC CAVITY, NO NEEDLE TIP OF ABOUT 2MM WAS FOUND. THE BEDSIDE ABDOMINAL PLAIN FILM EXAMINATION WAS PERFORMED, WHICH INDICATED THAT "SCATTERED INTESTINAL GAS AND CONTENTS CAN BE SEEN IN THE ABDOMEN, NO INTESTINAL DILATATION OR LIQUID LEVEL IS FOUND, AND THE ABDOMINAL FAT LINES ON BOTH SIDES ARE CLEAR. NO HIGH-DENSITY METAL FOREIGN BODY SHADOW IS FOUND IN THE ABDOMEN." RINSE AND ASPIRATE AGAIN AND AGAIN, AND CHECK THE ASPIRATED LIQUID, BUT THE DROPPED NEEDLE TIP WAS NOT FOUND. AFTER THE SURGERY , THE PATIENT WOKE UP WITHOUT COMPLAINT. THE INTESTINAL EXHAUST WAS SMOOTH AFTER THE SURGERY . THE PATIENT WAS DISCHARGED ON THE THIRD DAY AFTER THE SURGERY , AND THE OUTPATIENT DEPARTMENT WAS ORDERED TO CONDUCT REGULAR REEXAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379867 ↗
• MalfunctionAug 16, 2022Break

  IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING DURING HYSTERECTOMY SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY OUR DISTRIBUTOR INDICATED THE NEEDLE FELL INTO THE PATIENT'S BODY AND HAD TO BE RETRIEVED WITHOUT INCIDENT. NO SECOND SURGERY WAS PERFORMED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234963 ↗
• MalfunctionJun 1, 2022Break

  INITIAL COMPLAINT RECEIVED (B)(6) 2022 WITH MINIMAL DETAIL. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022, AFTER INVESTIGATION, THE PATIENT (FEMALE, SPECIFIC AGE UNKNOWN) UNDERWENT SURGERY ON (B)(6) 2022 (SPECIFIC PATIENT DIAGNOSIS AND SURGICAL NAME UNKNOWN). THE SURGEON USED SXPD1B401 FOR UTERINE TISSUE SEWING IN A CONTINUOUS SUTURE MANNER (SPECIFIC SUTURE TISSUE LEVEL UNKNOWN). AFTER THE COMPLETION OF SEWING, THE NURSE FOUND THAT THE NEEDLE TIP WAS SLIGHTLY MISSING (SPECIFIC MISSING LENGTH UNKNOWN). THE SURGEON IMMEDIATELY LOOKED FOR THE MISSING NEEDLE TIP AND FAILED TO FIND IT (THE SPECIFIC SEARCH METHOD WAS UNKNOWN). AFTER WASHING THE ABDOMINAL CAVITY OF THE PATIENT WITH A LARGE AMOUNT OF LIQUID, THE ABDOMEN WAS ROUTINELY CLOSED AND THE SURGERY WAS COMPLETED. THE BROKEN PART OF THE NEEDLE TIP WAS FINALLY NOT FOUND. THERE WAS NO HARM TO THE PATIENT AT PRESENT, THE PATIENT WAS IN STABLE CONDITION, AND NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14567757 ↗
• MalfunctionMay 5, 2022Material Fragmentation

  THE NEEDLE BROKE DURING SURGERY, WHILE SEWING THE UTERUS IN THE LAPAROSCOPIC MYOMECTOMY AND THE BROKEN PART FELL INTO THE PATIENT. IT TOOK OVER 1 HOUR TO LOOK FOR THE BROKEN NEEDLE WITH THE HELP OF A CT AND FINALLY IT WAS RETRIEVED AND REMOVED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288951 ↗
• MalfunctionAug 6, 2021Break

  THE HEALTH AUTHORITY REPORTED TO OUR DISTRIBUTOR THAT ON (B)(6) 2021, DURING A LAPAROSCOPIC HYSTEROMYOMECTOMY WAS PERFORMED, THE PROCESS OF SUTURING THE UTERINE INCISION, THE NEEDLE OF THE ABSORBABLE SURGICAL SUTURE BROKE INTO TWO PARTS. THE BROKEN NEEDLE WAS REMOVED SMOOTHLY AND COMPLETELY DURING THE OPERATION. THE SUTURE WAS REPLACED PROMPTLY TO COMPLETE THE SURGERY. THE OPERATION TIME AND THE OPENING TIME OF THE INCISION WERE PROLONGED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12287675 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL HYSTERECTOMY SURGERY ON (B)(6) 2020, AND THE DEVICE WAS USED TO SEW THE VAGINAL STUMP. ON (B)(6) 2021, THE PATIENT WENT BACK TO THE HOSPITAL FOR REEXAMINATION. THROUGH COLPOSCOPY, POLYPS WERE FOUND ON BOTH SIDES OF THE VAGINAL STUMP, THEN THE POLYPS WERE CUT OFF WITH LEEP KNIFE UNDER COLPOSCOPE. THE PATIENT IS STABLE NOW. THE CUSTOMER SUSPECT THAT THE SUTURE REJECTION IS TOO SERIOUS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11700326 ↗