MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC STAPLE NITINOL 10 X 10 FUSEFORCE; STAPLE, FIXATION, BONE

Model Number FFNS1010

Device Problem Mechanical Jam (2983)

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

Event Date 07/25/2022

Event Type  malfunction  

Event Description

It was reported that the drill bit cold welded to drill guide of a 10x10 fuseforce staple.There was a delay of about 5 minutes during the procedure.When the staple kit failed, the surgeon utilized a 2.0 cannulated screw to salvage the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

Please note that the number in g8 should start with (b)(4).The reported event could be confirmed, since the device was returned and examination found the plastic around the drill sleeves to be cracked and damage/deformation on the shaft of the drill bit.The device inspection revealed the following: examination finds the plastic around the guide sleeves is cracked.Damage to the drill shaft distal the fluting was also visible indicating the drill was most likely moved off axis while inside the sleeve.Striations were found near the bottom distal end of the handpiece that are consistent with a downward force while drill is under load.Functional inspection: functional test found that a test drill was able to slide in and out of both drill sleeve (151781) through holes without issue.Key dimensional measurements were taken of the drill and sleeve and all were found to be within specifications.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the drill being toggled while inside the drill sleeve.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 the drill bit cold welded to drill guide of a 10x10 fuseforce staple.There was a delay of about 5 minutes during the procedure.When the staple kit failed, the surgeon utilized a 2.0 cannulated screw to salvage the procedure.

• Brand Name: STAPLE NITINOL 10 X 10 FUSEFORCE
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15262454
• MDR Text Key: 303247684
• Report Number: 0001043534-2022-00004
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00840420127327
• UDI-Public: 00840420127327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124045
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FFNS1010
• Device Catalogue Number: FFNS1010
• Device Lot Number: 1704776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2021
• 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
• Patient Sex: Female
• Patient Race: White