MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.3X12MM CROSS-DRIVE SCREW; PLATE, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown 1.5mm drill, part# ni, lot# ni.Unknown ratcheting driver, part# ni, lot# ni.

Event Description

It was reported a screw fractured during an open reduction and internal fixation of a bilateral mandible fracture.The screw hole was prepared using a 1.5mm drill and the screw insertion was attempted with a ratcheting driver when the screw fracture occurred.The surgeon believes the dense bone of the patient and incorrect sizing of the drill is responsible for the screw fracture.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.

Event Description

It was reported that the fractured screw remained in the patient's bone.No additional patient consequences were reported.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.The screw 2.3x12mm cross-drive (item# 41-2312, lot# unk) was not returned for investigation and no photos, scans, x-rays, or physician's reported were provided.For these reasons, no functional testing or visual evaluations could be conducted.The dhr for this screw could not be reviewed due to the lot number remaining unknown.There are no indications of manufacturing defects.For this part (41-2312) in the previous one year (from the notification date), this was the only complaint (1 part total) regarding the fracturing of this screw, there is a complaint rate of 0.02% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause is the surgeon used the wrong size drill and therefore the incorrect pilot hole size was created.It was reported that the surgeon used a 1.5mm drill and ratcheting driver to insert the 2.3mm screw.The patient was also reported to have dense bone.It is also possible that the patient's dense bone contributed to the failure.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following fields were updated: b4 date of this report b5 describe event or problem g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

• Brand Name: TRAUMAONE SYSTEM 2.3X12MM CROSS-DRIVE SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10383020
• MDR Text Key: 202783099
• Report Number: 0001032347-2020-00362
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888233000451
• UDI-Public: 00888233000451
• Combination Product (y/n): N
• PMA/PMN Number: K081067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2020
• 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: 41-2312
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 34 YR