MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0X7MM BONE REDUCTION BLADE; ORTHOPAEDIC KNIFE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(4).

Event Description

It was reported the screw tip broke during an open reduction and internal fixation of a zygomatic fracture.The screw tip remained in the body without reduction.The bone was scraped and the screw tip fragment was removed from the patient.It was reported that no further information was available.

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.The following sections were corrected: d1, d2, d4, h4 the following sections were updated: b4, b5, d4, g3, g6, h2, h3, h6, h10 quantity of one 2.0x7mm bone reduction blade was returned for evaluation.Visual examination identified the tip to be fractured.The part and lot information were verified.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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: 2.0X7MM BONE REDUCTION BLADE
• Type of Device: ORTHOPAEDIC KNIFE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11086845
• MDR Text Key: 225058251
• Report Number: 0001032347-2020-00628
• Device Sequence Number: 1
• Product Code: HWI
• UDI-Device Identifier: 00841036145491
• UDI-Public: 00841036145491
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: SP-1889
• Device Lot Number: 933340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1