Quattro® Suture Passer Needle CM-9011Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00887868270147), received between Mar 6, 2020 and Jun 23, 2026 — classified as 10 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Fracture” (26 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Fracture

  IT WAS REPORTED THAT A SURGICAL NEEDLE BROKE INTRA-OPERATIVELY WHEN ACTIVATED WITHIN A TIGHT JOINT. THE DEVICE FRACTURED DURING ACTIVATION, AND ANOTHER STERILE NEEDLE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593176 ↗
• MalfunctionFeb 3, 2026Fracture

  IT WAS REPORTED THAT THE NEEDLE BROKE UPON INSERTION INTO A SUTURE PASSER AT THE BEGINNING OF THE CASE. ANOTHER DEVICE WAS USED AND THE PROCEDURE PROCEEDED WITHOUT ISSUE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247412 ↗
• MalfunctionAug 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE TIP BROKE OFF WHEN OPERATING THE SUTURE FORCEPS WITH BROADBAND. THE TIP WAS NOT FOUND. IT MAY HAVE BEEN ASPIRATED. THE DOCTOR TOOK AN X-RAY, BUT THE NEEDLE TIP IS NOT VISIBLE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895105 ↗
• MalfunctionJul 24, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586113 ↗
• MalfunctionJul 24, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586110 ↗
• MalfunctionJul 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT PRODUCT FRACTURED DURING SURGERY AND GOT STUCK INSIDE THE CLAMP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393869 ↗
• MalfunctionJun 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE NEEDLE TIP FRACTURED OFF WHEN SUTURING WITH THE SUTURE FORCEPS. THE TIP WAS REMOVED FROM THE PATIENT AND ANOTHER NEEDLE WAS USED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137118 ↗
• MalfunctionMay 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE SUTURE PASSER NEEDLE FRACTURED WHILE PLACING THE FIRST SUTURE. A FRAGMENT BROKE INSIDE THE PATIENT AND WAS ABLE TO BE REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061382 ↗
• InjuryApr 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF NEEDLE WAS FRACTURED AT ABOUT 1.0 MM FROM THE TIP DURING USE. THE SURGEON CONSIDERED REMOVING THE FRACTURED PIECE OF NEEDLE, OR NOT, BUT HE DECIDED TO FINISH THE SURGERY WITHOUT REMOVING THE FRACTURED PIECE OF NEEDLE FROM THE PATIENT'S BODY. SO, THE FRACTURED PIECE OF NEEDLE HAS BEEN RETAINED IN THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 21761862 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF NEEDLE WAS FRACTURED DURING USE. SO, THE SURGEON LOOKED FOR THE FRACTURED PIECE OF NEEDLE, AND HE COULD REMOVE THAT FROM THE PATIENT'S BODY FINALLY. IT TOOK ABOUT 1 HOUR TO REMOVE THE FRACTURED PIECE OF NEEDLE FROM THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739443 ↗
• MalfunctionFeb 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE TIP FRACTURED OFF. THERE WE NO ADVERSE EVENTS AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321449 ↗
• MalfunctionJan 31, 2024Fracture; Fracture

  IT WAS REPORTED THE NEEDLE WAS BROKEN OUT OF THE PACKAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614813 ↗
• InjuryNov 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE SUTURE PASSER NEEDLE FRACTURED DURING THE CASE. IMAGES OF THE RADIOGRAPH PROVIDED SHOW THAT THE NEEDLE IS RETAINED WITHIN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 18226707 ↗
• MalfunctionOct 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE PASSER NEEDLE INSTRUMENT WAS FOUND TO BE FRACTURED WHEN REMOVED FROM THE PACKAGING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT IMPACT OR ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT, TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850811 ↗
• MalfunctionJan 11, 2023Fracture; Fracture

  IT WAS REPORTED DURING SURGERY WHEN PASSING THE SUTURE IN A CUFF REPAIR, THE VERY TIP OF THE QUATTRO SUTURE PASSER NEEDLE BROKE OFF. THE TIP COULD NOT BE FOUND. ANOTHER SUTURE PASSER NEEDLE HAD TO BE OPENED IN ORDER TO COMPLETE THE CASE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142852 ↗
• MalfunctionMar 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE PASSER NEEDLE FRACTURED. FRACTURED PIECES WERE REMOVED FROM THE PATIENT AND A BACKUP PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13858897 ↗
• MalfunctionDec 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE QUATTRO SUTURE PASSER NEEDLE GOT STUCK AND BROKE INSIDE OF THE SUTURE PASSER DURING THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH ANOTHER DEVICE. THERE WAS NO IMPACT ON PATIENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111330 ↗
• MalfunctionOct 22, 2021Fracture; Fracture

  ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE, NO PRODUCT FELL IN PATIENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12680707 ↗
• MalfunctionJun 17, 2021Fracture; Fracture

  IT WAS REPORTED DURING A RIGHT SHOULDER ARTHROSCOPY CUFF REPAIR OPERATION, THE HOOK END (TIP END) FROM THE QUATTRO SUTURE PASSER WAS MISSING. ATTEMPTS WERE MADE TO FIND THE MISSING TIP BUT WERE NOT FOUND, IT WAS REPORTED TO NOT BE IN THE JOINT AND MOST LIKELY TO BE THE CUFF, SOFT TISSUE OR OUTSIDE OF THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12017310 ↗
• InjuryApr 2, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608879 ↗
• InjuryMar 23, 2021Fracture; Fracture

  IT WAS REPORTED A (B)(6) YEAR OLD UNDERWENT A SHOULDER ARTHROSCOPY LEFT/RCR. SUTURE PASSING NEEDLE BROKEN INTRA-OP, BROKEN NEEDLE WAS NOT FOUND, 1 MM X 2MM BROKEN TIP. SURGEON WAS AWARE OF THE LOST/BROKEN NEEDLE. THERE WAS NO SERIOUS INJURY OR PATIENT DEATH. SEARCHED DRAPES AND SURROUNDING AREAS BY SURGICAL TEAM. X-RAY WAS TAKEN IN THE OR, NO EVIDENCE OF NEEDLE IN PATIENT AFTER X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553431 ↗
• InjuryMar 8, 2021Break; Break

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11435044 ↗
• InjuryMar 8, 2021Break; Break

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11435029 ↗
• InjuryFeb 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING AN OPERATION, THE SURGEON POSITIONED THE DEVICE IN A "SCORPIO FORCEPS" DEDICATED TO PASS THE THREADS THROUGH A SOFT TISSUE. THE SURGEON HAD TO USE FORCE BUT IT WORKED. AT THE END OF THE OPERATION WHEN THE FORCEPS WERE REMOVED, IT WAS NOTICED THAT THE TIP OF THE CLAMP WAS MISSING. IT WAS DETERMINED THAT THE FRAGMENT IS IN THE SOFT TISSUE OF THE PATIENT'S SHOULDER BUT DOES NOT PRESENT ANY RISK. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11362176 ↗
• MalfunctionFeb 1, 2021Fracture; Fracture

  IT WAS REPORTED A SECOND FRACTURED DEVICE WAS RETURNED TO ZIMMER BIOMET. TECHNICAL EVALUATION IDENTIFIED THE TIP APPEARED TO BE BROKEN. REPORTER FOR THE LINKED COMPLAINT DOES NOT HAVE RECORD OF A SECOND FAULTY DEVICE OR INCIDENT OF FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11257924 ↗