Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PROPHECY TOE PLATE ATTACHMENT INBONE TOTAL ANKLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  • 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
 

WRIGHT MEDICAL TECHNOLOGY INC PROPHECY TOE PLATE ATTACHMENT INBONE TOTAL ANKLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number PTA00050
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2023
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that separating both components post procedure took excessive force which potentially damaged components.The instrument issue was discovered after surgery.No surgical delay, no additional patient adverse consequences.No other instruments/implants were used in combination with the affected instruments that may have contributed to this event.There was no adverse effect on surgical outcome.The procedure was completed successfully.
 
Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual examination of the returned device shows the device exhibits signs of wear.Scratches, dents and deformations can be seen around the pegs of the toe plate.The toe plate and c-bracket were able to be assembled and connected without any issues.However, disassembling the two parts required the use of excessive force as reported.An r&d engineer reviewed the received information and noted the following regarding the dimensions of the device: "there is always at least.0005 clearance between the parts.Since it is a small clearance, if they are not disassembling the parts at 90 degrees from each other it is possible for the parts to get wedged into each other and not disassemble easily, but this would be considered user error." based on investigation, the root cause was attributed to a combination of user and wear related issues.The failure was mostly likely caused by improper use of the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
 
Event Description
It was reported that separating both components post procedure took excessive force which potentially damaged components.The instrument issue was discovered after surgery.No surgical delay, no additional patient adverse consequences.No other instruments/implants were used in combination with the affected instruments that may have contributed to this event.There was no adverse effect on surgical outcome.The procedure was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROPHECY TOE PLATE ATTACHMENT INBONE TOTAL ANKLE
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY INC
1023 cherry rd
memphis TN 38117
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key17212575
MDR Text Key317966001
Report Number3010667733-2023-00347
Device Sequence Number1
Product Code LXH
UDI-Device Identifier00889797051996
UDI-Public00889797051996
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberPTA00050
Device Catalogue NumberPTA00050
Device Lot Number2487655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-