STRATAFIX SXPP1B102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031235755), received between Jun 29, 2018 and Oct 15, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANNICULECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT PA WAS USING BARBED SUTURE TO CLOSE DEEP DERMAL IN A PANNICULECTOMY CASE. AFTER THE FIRST PASS IN TISSUE THE SUTURE BROKE. IT IS BELIEVED THAT THE SUTURE/NEEDLE THAT IS BEING RETURNED IS THE CORRECT ONE THAT EXPERIENCED THE ISSUE BUT THE TECH WASN'T CERTAIN. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289679 ↗
• InjuryJun 29, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION TOTAL KNEE ARTHROSCOPY POLY SWAP PROCEDURE ON (B)(6) 2018 AND TOPICAL SKIN ADHESIVE WAS USED TO CLOSE THE INCISION. THE PATIENT REPORTED CLEAR AND YELLOW DRAINAGE THROUGH (B)(6) 2018. THE PATIENT RETURNED TO OFFICE AND THE PHYSICIAN ASSISTANT NOTICED EDGES STILL EVERTED, SLIGHTLY RED AND SOME YELLOW AND CLEAR DRAINAGE. ON (B)(6) 2018, THE PATIENT WENT ON A WALK AND THE KNEE FELT THE BEST IN TWO YEARS. THAT SAME DAY, THE PATIENT CAME DOWN WITH A FEVER OF 102 DEGREES AND KNEE BECAME VERY STIFF. EVALUATED MEDICATIONS AND THE FEVER BROKE WITH IBUPROFEN. ON (B)(6) 2018, THE PATIENT RETURNED FOR A KNEE WASHOUT AND CULTURES. THE CULTURE WAS TAKEN FROM THE SKIN ALL THE WAY THROUGH JOINT CAPSULE. THE DOCTOR OPENED THE KNEE AND NOTICED A SOUPY APPEARANCE AND SUTURE LINE APPEARED TO BE COMPROMISED. THE PATIENT HAD A NORMAL WEIGHT AND NO ADDITIONAL CO-MORBIDITIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Fever; No Code Available; Not Applicable; Unspecified Infection; Wound Dehiscence

  MAUDE report 7652880 ↗