MAUDE Adverse Event Report: OSTEOMED, LLC 10H ANTEROLATERAL TIBIA PLATE, LEFT; PLATE, FIXATION, BONE

Model Number	336-2110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported during the procedure, at the moment of inserting one of the non-locking screws, the plate broke.The surgeon used a longer plate to complete the procedure.This issue prolonged the procedure by 30 minutes.No other adverse patient consequences were reported.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no anomalies were noted.All inspections passed, and no issues were identified in the dhr review.The plate was returned for evaluation, and the reported issue of break was confirmed.The returned plate was fractured below one of the plate holes.As stated in the instructions for use (ifu), use of an undersized implant in areas of high functional stress may lead to implant fracture and failure.Additionally, bending the plate excessively multiple times may weaken the plate and could result in implant failure.The reported complaint was confirmed; however, based on the information received, a definitive root cause could not be determined.

• Brand Name: 10H ANTEROLATERAL TIBIA PLATE, LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 16049565
• Report Number: 2027754-2022-00212
• Device Sequence Number: 17743434
• Product Code: HRS
• UDI-Device Identifier: 00845694049818
• UDI-Public: (01)00845694049818(10)1133017(30)1(11)190102
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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 Model Number: 336-2110
• Device Catalogue Number: 336-2110
• Device Lot Number: 1133017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2019
• 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 Age: 50 YR
• Patient Sex: Male