MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PLANTAR PLATE IMPLANT SET GRAVITY PLANTAR PLATE REPAIR; SCREW, FIXATION, BONE

Catalog Number	86PPS1N0
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that both needles broke off of the suture when trying to pull through the plantar plate.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that both needles broke off of the suture when trying to pull through the plantar plate.
Additional Manufacturer Narrative
Correction - d5.The reported event could be confirmed, since an image provided does show the suture has disconnected from the needle.One image of the needle suture assembly was provided that appears to show the sutures from needle assembly have detached from the needle.However, no conclusion can be drawn based on the images alone.The op tech does note, "use a twisting or rotating motion to pass the needle through the tissue.Avoid pulling on the needle driver." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PLANTAR PLATE IMPLANT SET GRAVITY PLANTAR PLATE REPAIR
• Common Device Name: SCREW, 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: 18312694
• Report Number: 3010667733-2023-00759
• Device Sequence Number: 6832718
• Product Code: HWC
• UDI-Device Identifier: 00840420194602
• UDI-Public: 00840420194602
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170889
• 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): 05/01/2024

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 Catalogue Number: 86PPS1N0
• Device Lot Number: 1720582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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