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

Model Number	FFNS1010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0001043534-2022-00004
• Device Sequence Number: 17534445
• Product Code: JDR
• UDI-Device Identifier: 00840420127327
• UDI-Public: 00840420127327
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K124045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2026
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White