Maxon GMM-344LRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884523004786), received between Oct 26, 2017 and Aug 28, 2025 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K990951); 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY VETERINARY SURGERY, WHEN CLOSING THE LINEA ALBA OF A HORSE AT THE COMPLETION OF A COLIC PROCEDURE. THE THREE SUTURES BROKE MIDWAY THROUGH CLOSING THE INCISION SITE. AN ADDITIONAL PACKET OF SUTURE WAS OPENED IN PLACE OF THE DAMAGED ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916318 ↗
• MalfunctionAug 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY VETERINARY SURGERY, WHEN CLOSING THE LINEA ALBA OF A HORSE AT THE COMPLETION OF A COLIC PROCEDURE. THE THREE SUTURES BROKE MIDWAY THROUGH CLOSING THE INCISION SITE. AN ADDITIONAL PACKET OF SUTURE WAS OPENED IN PLACE OF THE DAMAGED ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916298 ↗
• MalfunctionAug 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY VETERINARY SURGERY, WHEN CLOSING THE LINEA ALBA OF A HORSE AT THE COMPLETION OF A COLIC PROCEDURE. THE THREE SUTURES BROKE MIDWAY THROUGH CLOSING THE INCISION SITE. AN ADDITIONAL PACKET OF SUTURE WAS OPENED IN PLACE OF THE DAMAGED ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916274 ↗
• MalfunctionAug 28, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY VETERINARY SURGERY, WHEN CLOSING THE LINEA ALBA OF A HORSE AT THE COMPLETION OF A COLIC PROCEDURE. THE SUTURE BROKE BEFORE THE NEEDLE WAS PASSED INTO THE HORSE. THE SUTURE WAS DISCARDED, AND ANOTHER PACKET WAS OPENED. THE SECOND PACKET ALSO BROKE, BUT AT THE END OF THE SUTURE LINE, WHEN THE KNOT WAS BEING TIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916150 ↗
• MalfunctionAug 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY VETERINARY SURGERY, WHEN CLOSING THE LINEA ALBA OF A HORSE AT THE COMPLETION OF A COLIC PROCEDURE. THE SUTURE BROKE BEFORE THE NEEDLE WAS PASSED INTO THE HORSE. THE SUTURE WAS DISCARDED, AND ANOTHER PACKET WAS OPENED. THE SECOND PACKET ALSO BROKE, BUT AT THE END OF THE SUTURE LINE, WHEN THE KNOT WAS BEING TIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916118 ↗
• MalfunctionAug 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CLOSURE OF FASCIA IN A DIAGNOSTIC LAPAROSCOPY, OPEN INCISIONAL HERNIA REPAIR, AND SMALL BOWEL RESECTION, THE SUTURE BROKE FROM THE SWAGE (CONNECTION OF NEEDLE AND THREAD) WHILE SUTURING. AN ADDITIONAL SUTURE WAS REQUIRED TO COMPLETE THE CLOSURE, AND THE PHYSICIAN RAN ANOTHER SUTURE FROM THE OTHER SIDE TO MEET IN THE MIDDLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814918 ↗
• MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN EXPLORATORY LAPAROTOMY, WHILE SUTURING THE FASCIA, THE CONNECTION OF THE NEEDLE AND THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737800 ↗
• InjuryNov 27, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, ONE DAY AFTER AN OPEN INCISIONAL HERNIA, THE SUTURE BROKEN WHILE THE PATIENT WAS RECUPERATING IN THE INTENSIVE CARE UNIT. THERE WAS A WOUND DEHISCENCE DUE TO THE ISSUE. THE PHYSICIAN USED ANOTHER NYLON SUTURE FROM A DIFFERENT MANUFACTURER TO CLOSE THE ANTERIOR FASCIA AGAIN. HOSPITALIZATION WAS EXTENDED.

  Patient problems: Laceration(s); Wound Dehiscence

  MAUDE report 20798855 ↗
• MalfunctionMar 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY WITH BOWEL RESECTION PROCEDURE, WHILE PERFORMING BOWEL ANASTOMOSIS AND CLOSING THE ABDOMEN, JUST BEFORE ITS USE, THE TWO NEEDLES CAME LOOSE FROM THE THREADS WITH THE FIRST THROW. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932568 ↗
• InjuryOct 20, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POST OPERATIVE, USED FOR CLOSING THE FASCIA, THE THREAD BROKE AFTER AT THE POINT THE TISSUE STARTED DYING. THE PATIENT WAS ILL WITH CHRONIC PERITONITIS. AFTER THEY WASH AND CLOSE THE WOUND THEY LEAVE IT OPEN TO PREVENT INFECTION. NO STEROIDS HAVE BEEN GIVEN TO THE PATIENT.

  Patient problems: Insufficient Information; Peritonitis

  MAUDE report 15640365 ↗
• InjuryOct 20, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POST OPERATIVE, USED FOR CLOSING THE FASCIA, THE THREAD BROKE AFTER AT THE POINT THE TISSUE STARTED DYING. THE PATIENT WAS ILL WITH CHRONIC PERITONITIS. AFTER THEY WASH AND CLOSE THE WOUND THEY LEAVE IT OPEN TO PREVENT INFECTION. NO STEROIDS HAVE BEEN GIVEN TO THE PATIENT.

  Patient problems: Insufficient Information; Peritonitis

  MAUDE report 15640301 ↗
• InjuryOct 20, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POST OPERATIVE, USED FOR CLOSING THE FASCIA, THE THREAD BROKE AFTER AT THE POINT THE TISSUE STARTED DYING. THE PATIENT WAS ILL WITH CHRONIC PERITONITIS. AFTER THEY WASH AND CLOSE THE WOUND THEY LEAVE IT OPEN TO PREVENT INFECTION. NO STEROIDS HAVE BEEN GIVEN TO THE PATIENT.

  Patient problems: Insufficient Information; Peritonitis

  MAUDE report 15640181 ↗
• InjuryOct 20, 2022Break; Break

  ACCORDING TO THE REPORTER, POST OPERATIVE OF OPEN EXPLORATORY LAPAROTOMY PROCEDURE, USED FOR CLOSING THE FASCIA, THE THREAD BROKE AFTER AT THE POINT THE TISSUE STARTED DYING. THE SURGEON TECHNIQUE EMPLOY WAS A LOOPED SUTURE THAT THEY CLOSED IN STANDARD CONTINUOUS FASHION STARTING WITH A V STITCH. 2 STRANDS WERE USED; ONE AT THE TOP OF THE INCISION AND ONE FROM THE BOTTOM AND THE RESIDENT RAN THEM TOGETHER. THE SURGEON TIED A STANDARD KNOT IN THE MIDDLE. THE PATIENT HAD A CHRONIC PERITONITIS. THE SUTURE WAS BINDING ON ITSELF AND NEED THE STAFF TO WET THE HANDS TO BE ABLE TO PUSH THE KNOT DOWN. AFTER THEY WASH AND CLOSE THE WOUND THEY LEAVE IT OPEN TO PREVENT INFECTION. NO STEROIDS HAVE BEEN GIVEN TO THE PATIENT. THE PATIENT HOSPITALIZATION WAS EXTENDED AND STILL ADMITTED. LEAVING THE PATIENT WITH A VENTRAL HERNIA THAT WILL REQUIRE A REPAIR WITH MESH.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 15639568 ↗
• InjuryOct 19, 2022Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON AN EXPLORATORY LAPAROTOMY, WHILE ON FASCIAL CLOSING, THE DOCTOR USED TWO LOOPED SUTURES TO CLOSE THE FASCIA; ONE AT EACH END OF THE INCISION. THE STITCHES WERE STARTED WITH A V STITCH THEN CLOSED BY THE RESIDENT IN A STANDARD CONTINUOUS FASHION. THE SURGEON TIED THE KNOTS AT THE END. THE TWO THREADS BROKE. THE SUTURES WERE BINDING ON ITSELF AND FELT STICKIER THAN USUAL. AFTER THE USER WASHED AND CLOSED THE WOUND, IT WAS LEFT OPEN TO PREVENT INFECTION. NO STEROIDS HAVE BEEN GIVEN TO THE PATIENT AND WAS STILL ADMITTED. THERE WAS AN UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE. THERE WAS DEAD FASCIA WHICH LEFT THE PATIENT WITH A VENTRAL HERNIA. IT WAS NOTED THERE WILL BE AN ADDITIONAL OPERATION PERFORMED TO CORRECT THE ISSUE. IT WAS NOTED THAT THE PATIENT WAS CRITICALLY ILL.

  Patient problems: Hernia; Necrosis; Peritonitis; Unspecified Tissue Injury

  MAUDE report 15633880 ↗
• MalfunctionAug 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ONLY INFORMATION THAT WAS GIVEN, THAT ON ALL THREE OF THE NEEDLE POPPED OFF.

  Patient problems: Insufficient Information

  MAUDE report 15249980 ↗
• InjurySep 19, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 1 DAY POSTOPERATIVE TO OPEN ABDOMINAL SURGERY, THE PATIENT HAD A COUGHING SPELL AND DEHISCED HIS FASCIAL CLOSURE. THIS RESULTED IN EMERGENT TAKEBACK TO THE OPERATING ROOM FOR CLOSURE OF THE FASCIAL DEHISCENCE WITH PLACEMENT OF RETENTIONSUTURES AS WELL. MORE SUTURES WERE ADDED TO CLOSE THE PATIENT'S ABDOMEN. HOSPITALIZATION WAS EXTENDED BY 1 DAY.

  Patient problems: Wound Dehiscence

  MAUDE report 12493555 ↗
• InjuryDec 13, 2019Break; Break

  ACCORDING TO THE REPORTER, 14 DAYS POSTOPERATIVE FROM AN OPEN HERNIA REPAIR, FASCIAL DEHISCENCE WAS NOTED. UPON VISUAL INSPECTION, THE SUTURE USED FOR THE PRIMARY FASCIAL CLOSURE BROKE. HERNIA REPAIR WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9468801 ↗
• MalfunctionJul 19, 2018Break

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, BOTH THE NEEDLE AND THREAD BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7703532 ↗
• MalfunctionJan 4, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, UPON APPLICATION ON ABDOMINAL WALL, THE SUTURE BROKE, HE WAS USING THE DEVICE WHEN CLOSING A LONG MIDLINE LAPAROTOMY INCISION. HE HAD CLOSED ABOUT 5-6 CM OF THE WOUND FROM ITS SUPERIOR ASPECT WHEN ONE OF THE TWO STRANDS BROKE FROM THE HUB OF THE NEEDLE. HE WAS ABOUT 1/3 TO /2 THE DISTANCE , HE WANTED TO BE BUT TOO FAR ALONG TO REMOVE THE SUTURE AND START OVER. HE STARTED A NEW SUTURE FROM INFERIOR ASPECT AND USED THAT ONE TO MEET THE OTHER. THEY OPENED ANOTHER PACKAGE OF SUTURE TO CLOSE THE ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7165828 ↗
• MalfunctionOct 26, 2017Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER: POST- OPERATIVELY 2.5 WEEKS ((B)(6)) AFTER DISTAL PANCREAS/ SPLENECTOMY /HIATAL HERNIA PROCEDURE, THE SUTURE WAS OBSERVED AS FALLING APART. IT WAS BEING APPLIED AT ANTERIOR FASCIA. TWO DOUBLE LOOP RUNNING TECHNIQUE WAS USED. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, USED ANOTHER SUTURE. PATIENT STATUS: RECOVERING W/ WOUND VAC. PATIENT' S MEDICAL HISTORY: FIBROMYALGIA, AUTOIMMUNE DISEASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6981124 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990951. One submission often covers many models, so check the product and lot details in each record.

• Z-2542-2017 · May 3, 2017 · Terminated
  Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: