MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC ANTEROLATERAL TIB PLATE LT SM ORTHOLOC 3DI PLATING SYSTEM; PLATE, FIXATION, BONE

Model Number	5888701L
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	01/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
The patient had a supramalleolar osteotomy 6 weeks ago, he fell on the day of the first surgery and fractured the opposite cortical bone (he was not x-rayed), now after 6 weeks the plate implanted at that time has broken due to the high load of the opening bone exactly there, where the constant movement has exerted pressure.Callus had already formed on the fragment of the cortical bone opposite the osteotomy.The plate was replaced and another plate was implanted on the opposite side for stability.
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual inspection: visual examination of the received product shows that it¿s broken through a shaft locking hole.Many scratches, dents and deformation are visible all over the implant from use, but afterwards it cannot be defined if these damages were caused during insertion or extraction.The microscopic examination of the fracture surface reveals the fracture to be a typical fatigue fracture evident by a smooth topography.Lines of rest are visible on both sides of the fracture.There are shiny surfaces on both fracture faces, which indicates that the fragments rubbed against each other after the breakage.The rest of the fracture face has the typical view of a fatigue fracture with an uniform fine-grained texture.The current instructions for use state: "potential complications and adverse reactions, in any surgical procedure, the potential for complications exists.The risks and complications with these implants include: ¿ infection or painful, swollen or inflamed implant site, ¿ fracture of the implant, ¿ loosening or dislocation of the implant requiring revision surgery, ¿ bone resorption or over-production, ¿ allergic reaction(s) to implant material(s), ¿ untoward histological responses possibly involving macrophages and/or fibroblasts, ¿ migration of particle wear debris possibly resulting in a bodily response, ¿ embolism," 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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
The patient had a supramalleolar osteotomy 6 weeks ago, he fell on the day of the first surgery and fractured the opposite cortical bone (he was not x-rayed), now after 6 weeks the plate implanted at that time has broken due to the high load of the opening bone exactly there, where the constant movement has exerted pressure.Callus had already formed on the fragment of the cortical bone opposite the osteotomy.The plate was replaced and another plate was implanted on the opposite side for stability.

• Brand Name: ANTEROLATERAL TIB PLATE LT SM ORTHOLOC 3DI PLATING SYSTEM
• Common Device Name: PLATE, 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: 16353108
• Report Number: 3010667733-2023-00062
• Device Sequence Number: 7029895
• Product Code: HRS
• UDI-Device Identifier: 00840420126740
• UDI-Public: 00840420126740
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K102429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: 5888701L
• Device Catalogue Number: 5888701L
• Device Lot Number: 1423974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2012
• 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 Sex: Male