• 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. TORPEDO, 4.0MM X 13CM; SAW BLADE

  • 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. TORPEDO, 4.0MM X 13CM; SAW BLADE Back to Search Results
Model Number TORPEDO, 4.0MM X 13CM
Medical Device Problem Code Device Damaged by Another Device (2915)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/05/2026
Type of Reportable Event Malfunction
Event or Problem Description
On 20-mar-2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8400td torpedo was damaged during use.While using the ar-8400td torpedo on the posterior horn of the lateral meniscus and performing the necessary reshaping, a loose meniscal suture was observed which the specialist removed with the torpedo.At which point, it be came evident that the inner blade was no longer rotating.The device was then inspected and it was found the inner blade was slightly bent.This was discovered during a knee chondroplasty procedure with no patient harm.No additional anesthesia was administered and the case was completed with another device.
 
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TORPEDO, 4.0MM X 13CM
Common Device Name
SAW BLADE
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
jared engle
8009337001
MDR Report Key24703168
Report Number1220246-2026-01685
Device Sequence Number10462884
Product Code GFA
Combination Product (Y/N)N
Initial Reporter CountryCO
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Company Representative
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date (Section B) 07/22/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberTORPEDO, 4.0MM X 13CM
Device Catalogue NumberAR-8400TD
Device Lot Number15394072
Was Device Available for Evaluation? No
Distributor Facility Aware Date03/05/2026
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/05/2026
Supplement Date Received by Manufacturer07/21/2026
Initial Report FDA Received Date03/26/2026
Supplement Report FDA Received Date07/22/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured02/24/2025
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
-
-