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

Model Number	FFNS1010
Medical Device Problem Codes	Component Missing (2306); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed, since images were obtained confirming the allegation.Evaluation of the manufacturing process determined the product mix could have occurred at the supplier or during production pull for the kit components.A nonconformance was opened to further investigation the incident.If more information is provided, the case will be reassessed.The device was discarded.
Event or Problem Description
It was reported that there was an opened solana staple and the drill size guide was for 12mm.Another implant was opened to fulfill the surgery needs and the other implant was disposed of.
Additional Manufacturer Narrative
Based on the reassessment of the available information and the initial reportability decision it was concluded that this event was filed as a mdr to the fda in error.The reported event did not cause or contributed to death or serious injury.The surgery was completed successfully without any patient or end user impact.Complaint history review determined there were no previous similar events involving this device that caused or contributed to death or serious injury.Evaluation of the manufacturing process determined the product mix could have occurred at the supplier or during production pull for the kit components.A nonconformance was opened to further investigate the incident.If additional information becomes available that suggests otherwise, the reporting decision will be reevaluated.
Event or Problem Description
It was reported that there was an opened solana staple and the drill size guide was for 12mm.Another implant was opened to fulfill the surgery needs and the other implant was disposed of.

• 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: 17038481
• Report Number: 3010667733-2023-00300
• Device Sequence Number: 15067809
• Product Code: JDR
• UDI-Device Identifier: 00840420127327
• UDI-Public: 00840420127327
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K124045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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 Model Number: FFNS1010
• Device Catalogue Number: FFNS1010
• Device Lot Number: 1751761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• 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 Age: 14 YR
• Patient Sex: Female