MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EASYFUSE¿; STAPLE, FIXATION, BONE

Catalog Number FFS42520

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

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

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation is anticipated but has not yet begun.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

The plastic block that the easyfuse staple is loaded on snapped upon trying to activate the distractor.This did not cause any delay in surgery as they had ez clip as a back up plan.

Event Description

It was discovered that this device was reported in error.The surgeon had no issues.

Manufacturer Narrative

It was discovered that this device was reported in error.The surgeon had no issues.

• Brand Name: EASYFUSE¿
• Type of Device: STAPLE, FIXATION, BONE
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 13261444
• MDR Text Key: 284373396
• Report Number: 3010667733-2022-00015
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FFS42520
• Device Lot Number: 1719962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 73 YR
• Patient Sex: Male