MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EASYFUSE STAPLE, MTP, L NITINOL, 4-LEG; STAPLE, FIXATION, BONE

Model Number	FFS4MTPS
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3: device disposition is unknown.
Event or Problem Description
It was reported that there was a revision surgery.The mtp staple was implanted but needed to be repositioned.When taken out and reloaded on to implant cartridge, the cartridge snapped and became unable to use.

• Brand Name: EASYFUSE STAPLE, MTP, L NITINOL, 4-LEG
• 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: 16800826
• Report Number: 3010667733-2023-00214
• Device Sequence Number: 14183165
• Product Code: JDR
• UDI-Device Identifier: 00889797103534
• UDI-Public: 00889797103534
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K203832
• 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
• Report Date (Section B): 04/24/2023

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: FFS4MTPS
• Device Catalogue Number: FFS4MTPS
• Device Lot Number: 1719966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown