Stratafix Spiral SXMD1B405Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031228061), received between Aug 6, 2021 and Jul 14, 2025 — classified as 13 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 20, 2022Open, Classified

   Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair

   Z-0150-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Separation Problem; Separation Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE DETACHED FROM THE SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, THERE WAS A DELAY IN SURGERY DUE TO INTERVENTION BEING REQUIRED TO REMOVE THE NEEDLE FROM THE PATIENT. NO ADDITIONAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502319 ↗
• InjuryMay 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2025 THAT INTRAOPERATIVELY THE SUTURE BROKE, LEADING TO THE NEEDLE DETACHING, AND THE INTESTINAL WALL BEING PUNCTURED BY THE NEEDLE. NO PATIENT INJURY WAS REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978847 ↗
• InjuryApr 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE BROKE, FELL INTO THE PATIENT AND ALL PIECES WERE RETRIEVED. NO PATIENT INJURY WAS REPORTED; HOWEVER, INTERVENTION WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21773231 ↗
• MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY OUR DISTRIBUTOR THAT DURING THE PROCEDURE, THE NEEDLE FELL INTO THE PATIENT. THE DOCTOR REMOVED IT AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106018 ↗
• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024 THE NEEDLE PULLED OFF THE SUTURE AND FELL INTO THE BODY. IT WAS IMMEDIATELY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878860 ↗
• InjuryDec 4, 2024Biocompatibility; Biocompatibility

  ON 31-OCT-2024, IT WAS REPORTED THAT A PATIENT'S SURGICAL SITE EXHIBITED REDNESS AND SUPPURATION. THE PATIENT WAS ADMITTED TO A HIGHER-LEVEL HOSPITAL FOR INFECTION CONTROL, WHERE THE SUTURE WAS REMOVED AND RE-SUTURED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20845769 ↗
• InjuryOct 14, 2024Biocompatibility; Biocompatibility

  CORZA MEDICAL / SURGICAL SPECIALTIES CORZA MEDICAL / SURGICAL SPECIALTIES WAS INFORMED ON 10/04/2024 THAT TWO PATIENTS EXPERIENCED POSTOPERATIVE INCISION INFECTIONS. THIS INFORMATION WAS OBTAINED FROM A CLINICAL STUDY AND REPORTED THROUGH CLINICAL LITERATURE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20440598 ↗
• InjurySep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  OUR AFFILIATE REPORTED THE NEEDLE DETACHMENT FROM THE SUTURE AND FELL INTO THE BODY CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340302 ↗
• InjurySep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2024 THAT A NEEDLE BROKE INTRAOPERATIVELY. THE NEEDLE WAS SUCCESSFULLY REMOVED FROM THE SITE AND NO PATIENT INJURY WAS REPORTED; HOWEVER, THE FAILURE RESULTED IN A SIGNIFICANT PROCEDURAL DELAY AND INTERVENTION WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20267156 ↗
• InjuryMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  OUR DISTRIBUTOR REPORTED THE PATIENT UNDERWENT A SURGICAL PROCEDURE. DURING THE SURGERY, THE DOCTOR USED SUTURE TO SUTURE THE WOUND FOR THE PATIENT. AFTER THE SUTURE WAS COMPLETED, A NEEDLE HOLDER WAS USED TO REMOVE THE NEEDLE FROM THE LAPAROSCOPIC PUNCTURE DEVICE. IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE NEEDLE HAD FALLEN INTO THE ABDOMINAL CAVITY. THE NEEDLE WAS IMMEDIATELY REMOVED UNDER THE DIRECT VIEW OF THE ENDOSCOPE, AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297212 ↗
• InjuryJan 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY OUR DISTRIBUTOR THAT THE NEEDLE BROKE DURING SEWING IN SURGERY. THE NEEDLE FELL INTO PATIENT''S BODY, THEN THE SURGEON LOOKED FOR THE NEEDLE AND REMOVED FROM PATIENT FINALLY. THE SURGERY WAS DELAYED FOR ABOUT 30 MINUTES. THE PATIENT IS STABLE NOW.

  Patient problems: Foreign Body In Patient

  MAUDE report 18605678 ↗
• MalfunctionOct 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTH AUTHORITY REPORTED TO OUR DISTRIBUTOR THE NEEDLE BROKE WHEN THE SURGEON ATTEMPTED TO SEW THE PERITONEUM. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17981300 ↗
• InjurySep 28, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  POOR WOUND HEALING. THE HEALTH AUTHORITY REPORTED TO OUR DISTRIBUTOR AFTER THE DOCTOR EXPERIENCED FOUR (4) INSTANCES, USING SUTURE FOR INTRADERMAL SUTURING, THE PATIENT''S WOUND EXPERIENCED SUTURE VOMITING, RESULTING IN POOR WOUND HEALING AND PROLONGED DRESSING CHANGE TIME, REQUIRING MORE FREQUENT DRESSING CHANGES. PERFORM MORE DRESSING CHANGES FOR THE PATIENT UNTIL THE WOUND HEALS.

  Patient problems: Retroperitoneal Hemorrhage

  MAUDE report 17840540 ↗
• MalfunctionJan 11, 2023Detachment of Device or Device Component

  OUR DISTRIBUTOR RECEIVED THE FOLLOWING REPORT FROM THE HEALTH AUTHORITY. THE PATIENT UNDERWENT LEFT RENAL TUMOR SURGERY AT 9 O''CLOCK, AND THE RENAL ARTERY WAS BLOCKED AT ABOUT 10 O''CLOCK. WHEN THE DOCTOR SUTURED THE KIDNEY WITH SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. AND THE NEEDLE WAS NOT ON THE SUTURE. THE NEEDLE WAS FOUND SEVEN MINUTES LATER.

  Patient problems: Insufficient Information

  MAUDE report 16141590 ↗
• InjuryOct 11, 2022Break; Device Fell

  THE NEEDLE BROKE DURING THE TUMOR SURGERY/BLOOD VESSEL BLOCKAGE. THE NEEDLE FELL INTO THE PATIENT'S BODY AND COULD NOT BE FOUND FOR OBSERVATION. BECAUSE OF EMERGENCY, THE TUMOR COULD ONLY BE SUTURED, THE BLOCKAGE WAS RELEASED, AND THE SEARCH CONTINUED, AND FINALLY THE NEEDLE WAS FOUND IN THE PATIENT'S BODY. AT PRESENT, THE PATIENT'S VITAL SIGNS ARE STABLE. PROCEDURE: LAPAROSCOPIC RESECTION OF RIGHT RENAL TUMOR UNDER GENERAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 15584658 ↗
• MalfunctionAug 30, 2022Break

  THE HEALTH AUTHORITY REPORTED THE FOLLOWING TO OUR DISTRIBUTOR. AT 09:30, THE SURGERY WAS CARRIED OUT. AT 10.50, WHEN THE PANCREAS WAS SEWED, THE NEEDLE WAS BROKEN. AFTER SEARCHING, THE BROKEN NEEDLE TIP WAS FOUND IN THE PRE PANCREATIC SPACE AND ALIGNED WITH THE TAIL. IT WAS DETERMINED THAT THE NEEDLE WAS COMPLETELY TAKEN OUT .

  Patient problems: Foreign Body In Patient

  MAUDE report 15322203 ↗
• InjuryJun 22, 2022Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE HEALTH AUTHORITY TO OUR DISTRIBUTOR THAT DURING A RADICAL GASTRECTOMY, THE NEEDLE TYPE WAS FOUND TO BE CUTTING NEEDLE WHEN OPENED THE PACKAGE, BUT ACTUALLY IT SHOULD BE A TAPER NEEDLE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. HOWEVER, THE HOSPITAL ONLY HAS THIS TYPE OF SUTURE, AND THE DOCTOR CAN ONLY USE THIS SUTURE FOR GASTROINTESTINAL ANASTOMOSIS, RESULTING IN GREAT DAMAGE TO THE PIPE WALL AND INCREASED BLEEDING DURING THE SEW PROCESS. THE DOCTOR USED OTHER SUTURE FOR REINFORCEMENT AGAIN. THIS LEADS TO THE NEED FOR INTERNAL AND SURGICAL TREATMENT TO AVOID THE ABOVE PERMANENT INJURY .

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14774553 ↗
• MalfunctionNov 19, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DOCTOR PERFORMED THE REPAIR OF GASTRIC PERFORATION. WHEN FINISHING SEWING, THE DOCTOR WAS ABOUT TO TAKE OUT THE SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. SO THERE WAS ONLY THE SUTURE WITHOUT THE NEEDLE. THE NEEDLE WAS NOT FOUND IN THE POSTERIOR ABDOMEN, AND THE IMAGING EXAMINATION REVEALED OBVIOUS DEVELOPMENT, AND FINALLY FOUND AND REMOVED. THE SURGERY WAS COMPLETED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847074 ↗
• InjuryAug 6, 2021Component Missing

  OUR DISTRIBUTOR REPORTED THAT THE PATIENT UNDERWENT GASTRIC STROMAL TUMOR SURGERY. WHEN SEWING THE COMMON SURGICAL INCISION OF GASTROINTESTINAL TISSUE, THE NEEDLE PULLED OFF THE SUTURE. X-RAY'S WERE USED TO LOOK FOR THE NEEDLE BUT IT COULD NOT BE FOUND. A CT SCAN WAS USED TO REMOVE THE NEEDLE. THE SURGERY WAS DELAYED FOR ABOUT 6 HOURS. THE PATIENT IS STABLE NOW.

  Patient problems: Insufficient Information

  MAUDE report 12287582 ↗