MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC IMPLANT SMALL CANNULATED PHALINX HAMMERTOE; SCREW, FIXATION, BONE

Catalog Number 45301002

Device Problems Device Dislodged or Dislocated (2923); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported that the implant was ripped out of the patients bone during removal of the handle in a hammertoe surgery.The implant was still used in the patient but with less bone purchase.

Manufacturer Narrative

Based on the available information the device will not be returned as it remains implanted in the patient.When additional information become available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.

• Brand Name: IMPLANT SMALL CANNULATED PHALINX HAMMERTOE
• Type of Device: 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: 18852160
• MDR Text Key: 337068587
• Report Number: 3010667733-2024-00137
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00840420166036
• UDI-Public: 00840420166036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 45301002
• Device Lot Number: 0084042016604300840420166036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Sex: Male