MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FUSEFORCE¿ FLEX DYNAMIC COMPRESSION SYSTEM; STAPLE, FIXATION, BONE

Catalog Number FFSP1530

Device Problem Difficult to Advance (2920)

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

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the drill did not fit through the universal drill guide for the easyfuse staple.

Manufacturer Narrative

The reported event could be partially confirmed, since the device was not returned for evaluation.However, the r&d team was able to recreate the issue with production parts.Based on investigation, the root cause was attributed to a design related issue.The failure was caused by the drill being run at full power prior to being engaged with the drill sleeve and a slight angular torque/pressure applied during use.Preliminary investigation suggests these prior conditions result in failure due to the drill and the drill sleeve are made of the same material and the fact the drill is not electropolished and the drill sleeve is not heat treated.A nonconformance was opened to further investigate this issue.

Event Description

It was reported that the drill did not fit through the universal drill guide for the easyfuse staple.

• Brand Name: FUSEFORCE¿ FLEX DYNAMIC COMPRESSION SYSTEM
• 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: 13237345
• MDR Text Key: 284373503
• Report Number: 3010667733-2022-00012
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FFSP1530
• Device Lot Number: 781853-110321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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