• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW, 5.0 LG, 42MM LGTH; PLATE, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARTHREX, INC. COMPR FT SCRW, 5.0 LG, 42MM LGTH; PLATE, FIXATION, BONE Back to Search Results
Model Number COMPR FT SCRW, 5.0 LG, 42MM LGTH
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem Unspecified Infection (1930)
Event Date 03/15/2022
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
On 9/6/2022, it was reported by a sales representative via phone that an ar-8750-42h, an ar-8750-46h, and an ar-8750-50h had issues.During a fulkerson osteotomy procedure on (b)(6) 2022, all three complaint devices were implanted, and the case was completed successfully with no impact to the patient.It was reported that the patient had a post-op infection three weeks after surgery.On (b)(6) 2022, the x-ray was showing that 2 of 3 screws were bending.On (b)(6) 2022, on the next x-ray, one of the screws had broken post-op inside the patient.On (b)(6) 2022, on the next x-ray, 2 of the 3 screws were broken inside the patient post-op.According to the x-ray and the sales representative, it was assumed that the ar-8750-50h and ar-8750-46h were broken.The broken screws were securely affixed inside the patient, and the surgeon was not planning a revision surgery and deemed it safe to leave the broken screws inside the patient, but just wanted to have the complaint reported.The patient is fine to date.On 9/26/2022, the sales representative provided the following additional information on the phone: the post-op infection three weeks after surgery had occurred on the surgical site of the patient.Additional information has been requested on how the infection was treated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COMPR FT SCRW, 5.0 LG, 42MM LGTH
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key15614884
MDR Text Key301829857
Report Number1220246-2022-05612
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00888867262928
UDI-Public00888867262928
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCOMPR FT SCRW, 5.0 LG, 42MM LGTH
Device Catalogue NumberAR-8750-42H
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/26/2022
Initial Date FDA Received10/17/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-