MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X5MM LACTOSORB SCREW

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Report source: 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

It was reported that when the packaging was opened, it contained a hair or thread.Another product was used to complete the surgery.It was reported that no further information is available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d9; g3; g6; h1; h2; h3; h6; h10.A visual inspection was conducted on the returned 915-2316 lot 339150 screw.The customer reported that a hair/ fiber was found in the package after opening the package.The visual inspection showed that there was indeed a hair/ fiber in the opened package.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The root cause of the reported event is the operator not following the provided work instructions during manufacturing.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 1.5X5MM LACTOSORB SCREW
• Type of Device: SCREW
• 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: 15569503
• MDR Text Key: 302474891
• Report Number: 0001032347-2022-00328
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036055196
• UDI-Public: (01)00841036055196(17)260828(10)339150
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• 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: 915-2316
• Device Lot Number: 339150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2021
• 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