MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB1.5MM 4HOLE EXTSTR PLATE; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported during the incoming inspection at a warehouse that a team member discovered a hair stuck to the packaging.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).G2: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned package.The customer reported a hair in the package.Upon receipt of the product seal was found to be partial open.A visual inspection of the package itself could not find the reported hair.As a result of the torn seal and the inability to find the reported hair the complaint cannot be confirmed.A determination cannot be made as to when the seal was opened.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, d9, g3, g6, h2, h3, h6, and h10.

• Brand Name: LACTOSORB1.5MM 4HOLE EXTSTR PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17426744
• MDR Text Key: 320071015
• Report Number: 0001032347-2023-00288
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036055493
• UDI-Public: (01)00841036055493(17)280324(17)65988369
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 915-2414
• Device Lot Number: 65988369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1