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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.
Event or Problem Description
It was reported that the fractured screw remained in the patient's bone.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional 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
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10383020
• Report Number: 0001032347-2020-00362
• Device Sequence Number: 2942504
• Product Code: JEY
• UDI-Device Identifier: 00888233000451
• UDI-Public: 00888233000451
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K081067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 08/04/2020; 11/24/2020
• Initial Report FDA Received Date: 08/08/2020
• Supplement Report FDA Received Date: 08/24/2020; 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 34 YR