NA 228143Recalls & reported problems
Depuy Mitek, LLC · Meniscal Deployment Gun with Malleable Graft Retractor · Class 1
Quick summary
This DePuy Mitek meniscal deployment gun is a handheld tool used to place anchors during knee meniscus repair. Many of the 312 reports describe the tool not working properly with the anchors used with it, and some describe it firing early or bending. There were 15 injury reports and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 325
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 325 adverse event reports that list this exact device (DI 10886705010059), received between Mar 27, 2018 and Sep 30, 2026 — classified as 15 injuries, 310 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (177 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility177
- Positioning Failure36
- Material Deformation27
- Premature Activation21
- Activation, Positioning or Separation Problem16
- Use of Device Problem13
- Mechanical Jam12
- Firing Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions206
- No Consequences Or Impact To Patient101
- No Code Available13
- Not Applicable11
- Injury5
- No Known Impact Or Consequence To Patient5
- Tissue Damage5
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 325 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952184 ↗MalfunctionSep 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951653 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938090 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938085 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935389 ↗MalfunctionSep 28, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920414 ↗MalfunctionSep 28, 2026Appropriate Device Problem Term/Code Not Available
It was reported that during service and evaluation, it was determined that the MENISCAL DEPLOYMENT GUN device spring pusher tip was deformed. It was noted in the service order that the device could not fix the meniscus after deployment during a meniscal repair surgical procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914647 ↗MalfunctionSep 25, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
It was reported that during a meniscal repair surgical procedure, after the 1st firing of the OMNISPAN MENISCAL REPAIR 27DEG anchor device, it was observed that two plates were deployed at the same time. it was further observed that the sleeve of the MENISCAL DEPLOYMENT GUN device was detached from the needle. During in-house engineering evaluation, it was determined that the spring pusher was found bent. It was reported that another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895777 ↗MalfunctionSep 22, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860286 ↗MalfunctionSep 21, 2026Material Fragmentation; Appropriate Device Problem Term/Code Not Available
It was reported that during service and evaluation, it was determined that the MENISCAL DEPLOYMENT GUN device spring pusher was found bent and broken. It was noted in the service order that the device double deployed. After the 1st firing, two plates were deployed at the same time. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839125 ↗MalfunctionSep 16, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785608 ↗MalfunctionSep 14, 2026Device Damaged Prior to Receipt by User; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763379 ↗MalfunctionSep 14, 2026Device-Device Incompatibility
This is report 1 of 2 of (b)(4).It was reported that during Meniscal Repair surgery, the MENISCAL DEPLOYMENT GUN device would not release. The device would not release after being fired, resulting in the needle not being able to be removed from the meniscal gun device. The device was in use with an unknown implant. There was no issue with the needle. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754018 ↗MalfunctionSep 8, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676574 ↗MalfunctionAug 27, 2026Material Deformation
It was reported that during service and evaluation, it was determined that the MENISCAL DEPLOYMENT GUN device was Deformed/Bent. It was noted in the service order that the device had an unspecified malfunction. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50483370 ↗MalfunctionAug 24, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418544 ↗MalfunctionAug 19, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50323769 ↗MalfunctionAug 12, 2026Nonstandard Device; Device Damaged Prior to Receipt by User
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225978 ↗MalfunctionJul 27, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50034505 ↗MalfunctionJul 20, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25870897 ↗MalfunctionJul 15, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825341 ↗MalfunctionJul 8, 2026Material Deformation
IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE, WHEN USING THE MENISCAL DEPLOYMENT GUN DEVICE WITH THE OMNISPAN MENISCAL REPAIR 12DEG ANCHOR DEVICE, IT WAS OBSERVED THAT AFTER THE 1ST FIRING, TWO PLATES WERE DEPLOYED AT THE SAME TIME. IT WAS REPORTED THAT THE SURGEON USED 2X ADDITIONAL OMNISPAN MENISCAL REPAIR 12DEG ANCHOR DEVICES, AND THE SAME PROBLEM HAPPENED AGAIN. IT WAS REPORTED THAT THE SPRING PUSH ROD OF THE MENISCAL GUN WAS BENT. IT WAS REPORTED THAT THE SURGEON USED A SIMILAR MENISCAL GUN AND A SIMILAR OMNISPAN DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 4 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25756549 ↗MalfunctionJul 8, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, THE OMNISPAN ORTHOCORD THE 2ND PLATE WAS DETACHED BEFORE DEPLOYMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE SPRING PUSHER TIP OF THE MENISCAL DEPLOYMENT GUN DEVICE WAS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754043 ↗MalfunctionJun 26, 2026Migration
IT WAS REPORTED THAT DURING MENISCAL REPAIR SURGERY, THE MENISCAL DEPLOYMENT GUN DEVICE 2ND PLATE DETACHED FROM THE MENISCUS AFTER DEPLOYMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25636063 ↗MalfunctionJun 15, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE THE MENISCAL DEPLOYMENT GUN DEVICE COULD NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25511572 ↗
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- GII 212094Depuy Mitek, LLC · APPLIER, STAPLE, SURGICAL,1 report
- RIGIDFIX 213704Medos International Sàrl · APPLIER, STAPLE, SURGICAL,1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.