MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PLATE, TIBIA FIBULA STRAIGHT, 8 HOLE

Catalog Number	MPPA508U
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by orthopedic foot and ankle surgeon (b)(6) that two years after implantation an 8-hole one-third tubular plate and 3.5 screws had gone through the plate.X-rays provided.Surgeon reports, "i am getting a ct scan and plan to do hardware removal." additional email received by (b)(6), who states, "i'm taking the plate out on 7/21.Will send info that day." no further information or details have been provided related to the reported incident.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported, "screws went through plate two years after implantation.".
Event or Problem Description
It was reported, "screws went through plate two years after implantation.".
Additional Manufacturer Narrative
Supplemental documentation changed/additional information added.Device available for evaluation -n/a type of report - follow-up, 01 if follow-up what type? additional information, device evaluated by manufacturer - n/a type of investigation- 4109, 4110, 4112, 4120 investigation conclusion zcd00005/defect confirmed: unknown responsible party.Investigation report reads as follows: 08/03/2021 10:58:27 cst (jskepnek)."medline quality received a complaint for mppa508u, no lot number was reported.This is in concern to the screw going through the plate two years after implantation.We received x-rays and confirmed the complaint.We did a retrospective query on the product family, and found no trends.An mdr, was filed, physician will retrieve samples.Complaint will remain open until we receive samples." (b)(6) 2021 13:17:04 cst (jskepnek)."after multiple attempts to try and receive more information and retrieving the sample from both the sales rep and the surgeon, we were unable to get a response.While we can confirm the complaint with the x-ray received, we are unable to determine the root cause without the physical sample.If the sample becomes available, we will reopen the complaint.The division will closely monitor this complaint during quarterly trending.".

• Common Device Name: PLATE, TIBIA FIBULA STRAIGHT, 8 HOLE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12163350
• Report Number: 1417592-2021-00110
• Device Sequence Number: 12073267
• Product Code: HRS
• UDI-Device Identifier: 10080196015023
• UDI-Public: 10080196015023
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MPPA508U
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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