MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE UNITE; PLATE, POSTEROLATERAL TIBIA, SML, RIGHT

Model Number	MPPA401R
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during ankle fracture surgery, the surgeon identified that 2 of the screws that were placed had gone through the posterolateral tibia plate and into the patient's bone.When this was identified, the surgeon removed the screws and the plate from the patient and then re-applied and re-secured the plate and screws.There was no further incident reported.There was no adverse patient impact and no further medical intervention or follow-up care was needed.No sample was available to be returned to the manufacturer for evaluation.Due to the reported need for medical intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that 2 screws were found to have gone through the posterolateral tibia plate.

• Brand Name: MEDLINE UNITE
• Common Device Name: PLATE, POSTEROLATERAL TIBIA, SML, RIGHT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11613129
• Report Number: 1417592-2021-00066
• Device Sequence Number: 3496559
• Product Code: HRS
• UDI-Device Identifier: 10884389013816
• UDI-Public: 10884389013816
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: MPPA401R
• Device Catalogue Number: MPPA401R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR