MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. ORTHOLOC 3DI PLATING CHECK SYSTEM; PLATE, FIXATION, BONE

Model Number 5820MPX1R

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2021

Event Type  malfunction  

Manufacturer Narrative

No device available for return.If additional information becomes available, it will be provided on a supplemental report.

Event Description

The customer reported that the loan crosscheck module did not contain any of the required mtp crosscheck plates.This was the plate that was needed for this procedure.The surgeon could not use his preferred implant.A different implant was used to complete the case.The surgeon further mentioned the patient may suffer from skin irritation going forwards by using a thicker plate in the patient.

• Brand Name: ORTHOLOC 3DI PLATING CHECK SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12450335
• MDR Text Key: 270800742
• Report Number: 0001043534-2021-00175
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00840420187048
• UDI-Public: 00840420187048
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5820MPX1R
• Device Catalogue Number: 5820MPX1R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1