MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTO 14MM RAPIDFLAP CLAMP; CRANIOFACIAL FIXATION PLATE, BIOABSORBABLE

Catalog Number 915-0020

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/10/2021

Event Type  malfunction  

Event Description

It was reported that the device was disassembled during usage.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Lacto 14mm rapidflap clamp cat# 915-0020 lot# 059540 the device was reported to be disassembled during usage.Upon visual examination of the provided pictures, the device was found to be fractured.The part and lot information was verified.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00269.

• Brand Name: LACTO 14MM RAPIDFLAP CLAMP
• Type of Device: CRANIOFACIAL FIXATION PLATE, BIOABSORBABLE
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12860800
• MDR Text Key: 285078596
• Report Number: 0001032347-2021-00540
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 0084103605386
• UDI-Public: (01)0084103605386(17)240510(10)059540
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K003281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 915-0020
• Device Lot Number: 059540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Male