Agee Digit Widget® DWD-232Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00861994000212), received between Dec 13, 2017 and Aug 16, 2022 — classified as 32 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (27 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM ON (B)(6) 2021. PATIENT REPORTED ON (B)(6) 2022 THAT DURING LAST YEARS CASE HE DEVELOPED A PIN SITE INFECTION THAT WAS TREATED WITH ORAL ABX AND THE DEVICE WAS REMOVED PRIOR TO COMPLETION OF TREATMENT.

  Patient problems: Bacterial Infection

  MAUDE report 15234242 ↗
• InjuryJun 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. SURGEON REPORTED "TREATED W ABX BUT ULTIMATELY THE PINS HAD TO BE REMOVED (WE TRIED TO SUPPRESS FOR A FEW WEEKS). PATIENT KEPT GETTING PURULENCE FROM THE WOUND." REMOVED THE DEVICE ATER "4 WEEKS OR SO" PRIOR TO COMPLETION OF CASE.

  Patient problems: Bacterial Infection

  MAUDE report 14686009 ↗
• InjuryMay 31, 2022Defective Component; Manufacturing, Packaging or Shipping Problem; Defective Component; Manufacturing, Packaging or Shipping Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. SURGEON CALLED TO REPORT HE WAS UNABLE TO INSTALL THE DISTAL BONE PIN DUE TO AN OBSTRUCTION IN THE DRILL GUIDE TUBE. HE SAID X-RAYS SHOWED AN "OCCLUDED HOLE" AND THE OBJECT LOOKED LIKE A DRILL BIT. SURGEON WAS ABLE TO COMPLETED THE CASE WITH PARTS FROM A 2ND DIGIT WIDGET SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547699 ↗
• InjuryMar 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. HAND BIOMECHANICS LAB RECEIVED DEVICE REGISTRATION FORM 6 DAYS POST OPERATIVELY WITH COMMENT 'BONE PIN DISTAL LODGED IN PIN BLOCK DEVICE. 2ND KIT USED ONLY DISTAL PIN AND PIN BLOCK". THERE IS NO FORESEEABLE WAY FOR THE PIN TO BECOME STUCK IN THE COMPONENT HAND BIOMECHANICS LAB CALLS THE 'PIN BLOCK'; HOWEVER, IT IS CONCEIVABLE THAT THE DRILL GUIDE COULD BE CALLED A PIN BLOCK BY A USER. THIS CASE IS THEREFORE POTENTIALLY SIMILAR TO CASES WHERE A NICK WAS CREATED IN THE BONE PIN WHEN AN ADJACENT PIN IS CUT, CAUSING A BURR AND PREVENTING THE DRILL GUIDE FROM BEING REMOVED FROM THE PIN. SURGEON WAS ABLE TO BACK-OUT THE PIN THAT WAS STUCK AND COMPLETED THE CASE WITH PARTS FROM A 2ND DIGIT WIDGET SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 13734622 ↗
• InjuryDec 16, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. SURGEON REPORTED DEVICE WAS REMOVED PRIOR TO COMPLETION OF TREATMENT AND ANTIBIOTICS WERE PRESCRIBED DUE TO A PIN SITE INFECTION. INFECTION CLEARED.

  Patient problems: Bacterial Infection

  MAUDE report 13021779 ↗
• InjuryMar 8, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. PATIENT REPORTED 68 DAYS POST OPERATIVE THAT HE HAD TWO 'PIN TRACT INFECTION IN THREE WEEKS'. 'THE PROXIMAL PIN ALSO BECAME LOOSE' AND THE PATIENT 'REMOVED THE SCREWS AT HOME'.

  Patient problems: Bacterial Infection

  MAUDE report 11436401 ↗
• InjuryFeb 18, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. PHYSICIAN REPORTED 50 DAYS POST OPERATIVE THAT 'PATIENT HAS DEVELOPED A GRANULOMA AT THE DISTAL PIN', THAT THE SITE WAS NOT INFECTED, AND 'WILL ADDRESS THE GRANULOMA WITH SILVER NITRATE'.

  Patient problems: Granuloma

  MAUDE report 11343770 ↗
• InjuryFeb 3, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. PATIENT REPORTED 24 DAYS POST OPERATIVE THAT HE WAS GIVEN PRESCRIPTION ANTIBIOTICS FOR A PIN SITE INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 11274118 ↗
• InjuryJan 26, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEMS. SURGEON REPORTED 18 DAYS POST OPERATIVE THAT PATIENT WAS GIVEN PRESCRIPTION ANTIBIOTICS FOR PIN SITE INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 11229558 ↗
• InjuryDec 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEMS. PATIENT REPORTED 13 DAYS POST OPERATIVE THAT HE WAS GIVEN PRESCRIPTION ANTIBIOTICS FOR A PIN SITE INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 11088220 ↗
• InjuryJul 9, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. THE PATIENT REPORTED THAT 8 DAYS POST OPERATIVE HE VISITED AN EMERGENCY ROOM FOR PAIN AND SWELLING WHERE HE WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 10252790 ↗
• InjuryJun 30, 2020Human-Device Interface Problem; Human-Device Interface Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. THE SURGEON EMAILED HAND BIOMECANICS LAB 23 DAYS POST OPERATIVELY AND REPORT 'THE DISTAL PIN WAS STUCK IN THE HOLE AND I HAD TO DESTROY THE DRILL GUIDE WITH A BURR TO BE ABLE TO GET IT OUT.' IN SUMMARY THE SURGEON WAS UNABLE TO REMOVE THE DISTAL PIN FROM THE DRILL GUIDE TUBE OF THE DRILL GUIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10212514 ↗
• InjuryMay 5, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL TWO DIGIT WIDGET EXTERNAL FIXATION SYSTEMS. PATIENT REPORTED 6 WEEKS POST OPERATIVE THAT HE HAD AN INFECTION ON 2 FINGERS AND IS ON ORAL ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 10026788 ↗
• InjuryMay 5, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL TWO DIGIT WIDGET EXTERNAL FIXATION SYSTEMS. PATIENT REPORTED 6 WEEKS POST OPERATIVE THAT HE HAD AN INFECTION ON 2 FINGERS AND IS ON ORAL ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 10026787 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. PATIENT REPORTED 4 DAYS POST OPERATIVE THAT HE EXPERIENCED A CONTACT ALLERGIC REACTION TO THE NEOPRENE CUFF, A NON-INVASIVE POST SURGERY COMPONENT OF THE DEVICE. HE WENT TO THE ER WITH A SWOLLEN HAND COVERED WITH BLISTERS: IN ADDITION TO TROUBLE BREATHING. HE WAS GIVEN PREDNISONE AND A TOPICAL TREATMENT AND HE STOPPED WEARING THE CUFF, LATEX BANDS AND CONNECTOR ASSEMBLY.

  Patient problems: Swelling

  MAUDE report 9883951 ↗
• InjuryFeb 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. PHYSICIAN REPORTED HIS PATIENT'S FINGER STRAIGHTENED BUT PRESENTED WITH OSTEOMYELITIS POST DW REMOVAL. SURGICAL DEBRIDEMENT WAS PERFORMED AND THE PATIENT IS 3 WEEKS INTO A 6 WEEK COURSE OF ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 9694304 ↗
• InjuryFeb 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. A HAND PHYSICAL THERAPIST REPORTED 2 WEEKS POST OPERATIVE THAT THE PATIENT WAS BEING TREATED WITH ORAL ANTIBIOTIC FOR A POSSIBLE PIN TRACT INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 9676912 ↗
• InjuryJul 1, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. PHYSICIAN REPORTED "BY THE 4 TH WEEK" "THE FINGER BECAME SWOLLEN". "THERE IS NO DRAINAGE OR REDNESS BUT I PUT HIM ON ABX."

  Patient problems: Bacterial Infection

  MAUDE report 8750156 ↗
• InjuryJun 7, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. OCCUPATIONAL THERAPIST REPORTED 17 WEEKS POST THAT "PATIENT GOT AN INFECTION - HAS HAD SEVERAL ROUNDS OF ANTIBIOTICS". INFECTION REFERS TO PIN TRACT INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 8679650 ↗
• InjuryFeb 20, 2019Human-Device Interface Problem; Human-Device Interface Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. THE SURGEON CONTACTED (B)(6) LAB DURING SURGERY AND REPORTED THE DRILL GUIDE WAS 'STUCK ON THE SKIN' AND THEY COULD NOT REMOVE IT FROM THE FIXATION PINS. METHODS USED TO REMOVE THE DRILL GUIDE RESULTED IN BENT FIXATION PINS. THEY DID NOT HAVE BACK-UP FIXATION PINS AND THE CASE WAS ABANDONED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353861 ↗
• InjuryJan 31, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. PHYSICAL THERAPIST REPORTED THAT PATIENT PRESENTED WITH RED SWOLLEN FINGER AT 2 WEEKS POST OPERATIVE AND PHYSICIAN PRESCRIBED ORAL ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 8294088 ↗
• InjuryNov 21, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL THREE DIGIT WIDGET EXTERNAL FIXATION SYSTEMS. THE PHYSICIAN REPORTED THAT HE 'HAD TO PULL ONE OF THE PINS, THE PROXIMAL ONE' ON 1 OF THE 3 DEVICES BECAUSE 'IT WAS INFECTED'.

  Patient problems: Bacterial Infection

  MAUDE report 8095010 ↗
• InjuryOct 19, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. AT 3 WEEKS POST OPERATIVE, THE PHYSICIAN REPORTED THAT PATIENT CALLED HIM REGARDING A "MILD REDNESS AROUND THE PROXMIAL PIN". REDNESS WENT AWAY AFTER A 10 DAY TREATMENT WITH ORAL ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 7984991 ↗
• InjuryAug 22, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT, WITH 'CHRONIC PAIN ISSUES FROM CTR', HAD SURGERY TO INSTALL THE DIGIT WIDGET EXTERNAL FIXATION SYSTEM. PHYSICIAN REPORTED, "PINS LOOSENED AND REQUIRED REMOVAL." "NO EVIDENCE OF INFECTION. HE DID HAVE INCREASING PAIN AND WAS STARTED ON ABX FOR POSSIBLE PIN TRACT INFECTION."

  Patient problems: Bacterial Infection

  MAUDE report 7805672 ↗
• InjuryJul 2, 2018Device Contamination With Biological Material; Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT HAD SURGERY TO INSTALL THE DIGIT WIDGET EXTERNAL FIXATION SYSTEM. PHYSICIAN REPORTED, "PATIENT DEVELOPED PIN TRACT INFECTION AND REQUIRED EARLY REMOVAL OF DEVICE, IS ON HUMIRA FOR PA AND IMMUNOSUPPRESSED." DEVICE REMOVED AFTER 8 WEEKS OF TREATMENT.

  Patient problems: Bacterial Infection

  MAUDE report 7654928 ↗