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

Model Number	RETIRED
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had foot surgery on (b)(6) 2020 at (b)(6) surgery center for hmt left 2nd, 4th, and 5th toes.Procedure was to straighten out left 4th and 5th, fuse 2nd left and place the wright medical phalanx implant-part# 05-042 into left 2nd toes.The patient continued to have problems with the foot, and this caused the patient to go to another foot doctor for review.The doctor determined that the implant failed and needed to be removed.The patient had surgery on (b)(6) 2023 to remove the toe implant and repair the toe.Operative report indicated that there was a leaching of metal inside the bone.Slivers of the base of the intermediate phalanx and head of the proximal phalanx were transected and sent off to pathology.Bone graft and k-wire was done to correct the toe.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Device disposition is unknown.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Upon further investigation of the provided images by healthcare professionals the following was observed, ¿leaching is not likely, but cannot be excluded.The biocompatibility of the implant has been proved, the interaction with the surrounding tissue is not likely to be an issue." regarding the image of discoloration at the implant site, "the discoloration of the surrounding tissue is common.Usually, no negative effect is known by this effect." the phalinx implant is manufactured from a titanium alloy commonly used in the medical implant industry.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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The patient had foot surgery on (b)(6) 2020 at lakes surgery center for hmt left 2nd, 4th, and 5th toes.Procedure was to straighten out left 4th and 5th, fuse 2nd left and place the wright medical phalanx implant-part# 05-042-into left 2nd toes.The patient continued to have problems with the foot, and this caused the patient to go to another foot doctor for review.The doctor determined that the implant failed and needed to be removed.The patient had surgery on 02/15/2023 to remove the toe implant and repair the toe.Operative report indicated that there was a leaching of metal inside the bone.Slivers of the base of the intermediate phalanx and head of the proximal phalanx were transected and sent off to pathology.Bone graft and k-wire was done to correct the toe.

• Brand Name: IMPLANT MEDIUM CANNULATED PHALINX HAMMERTOE NON CE
• 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: 16724737
• Report Number: 3010667733-2023-00188
• Device Sequence Number: 7949943
• Product Code: HWC
• UDI-Device Identifier: 00840420166128
• UDI-Public: 00840420166128
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RETIRED
• Device Catalogue Number: 05-042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female