MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC LESS MET T PLATE 7 HOLE ORTHOLOC PLATING SYSTEM; PLATE, FIXATION, BONE

Catalog Number	5201000204
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient returned to the emergency room with pain and when taking x-ray they realize that the plate is broken just days after surgery.
Additional Manufacturer Narrative
Correction d9, h3, h6 method.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: one plate and six screws were received for evaluation.The screws appear intact with no visible signs of deformation or damage.The plate was received broken in two separate pieces.Significant wear, scratches and deformation can be seen on the broken plate.The fracture surface exhibits signs of a brittle fracture.The nature of the fracture is consistent with breakage resulting from substantial mechanical stress due to sudden or excessive load.Upon further investigation of the x-ray images by healthcare professionals the following was observed: ¿the plate position seems to be where it was supposed by the surgeon.From a biomechanical perspective, however, it could not have been performed more unfavorable.The mtp joint is flexed with the whole body weight, while walking.Only one step could put enough load on the plate to brake.It looks as if the patient has, intentionally or not, placed full load on the plate.Due to the dorsal placement of the plate, the load would prevent the arthrodesis from union.Therefore, other specific devices or treatment methods exist, which would address the load/biomechanics better.Conclusion: patient related-excessive load on the device led to breakage.Surgeon related-unfavorable position of the plate and selection of the treatment method.¿ based on investigation, the root cause was attributed to a combination of patient and surgeon related factors.The failure was caused by the patient placing excessive load on the device and surgeon¿s unfavorable positioning of the plate.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.The current instructions for use was reviewed and states: ¿abnormal force loading, and subsequent wear may be caused by implant malposition and patient misuse or overactivity.It is imperative that adequate post-operative care and protection be provided by the surgeon.¿ no indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient returned to the emergency room with pain and when taking x-ray they realize that the plate is broken just days after surgery.

• Brand Name: LESS MET T PLATE 7 HOLE ORTHOLOC 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: 19387613
• Report Number: 3010667733-2024-00307
• Device Sequence Number: 4036304
• Product Code: HRS
• UDI-Device Identifier: 00840420124388
• UDI-Public: 00840420124388
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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 Catalogue Number: 5201000204
• Device Lot Number: 1374799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2014
• 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: Other
• Patient Age: 45 YR
• Patient Sex: Male