MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE 12MM CROSS DRIVE LOCKING SCREW

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D10: medical product - zimmer biomet traumaone 12mm cross drive locking screw catalog #: 41-2412 lot #: 65974347.G2: foreign - china.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2024-00023.
Event or Problem Description
It was reported that during a reconstructive surgery, the surgeon pre-drilled holes and then used an unknown tool to insert them.When the implantation was almost complete, the screws fractured.Attempts have been made and no further information has been provided.
Event or Problem Description
It was further reported that the surgery was on the lower jawbone and another screw was used to complete the surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product - zimmer biomettraumaone blade cross drive catalog #: 46-1005 lot #: unknown; zimmer biomet 1.5/2.0 driver catalog #: 01-7390 lot #: unknown; zimmer biomet drill catalog #: 46-1006 lot #: unknown the following section was corrected: e1.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned screws.Both screws show signs of use including marking and scratching on the screw surfaces.The visual inspection also showed that both screws have fractured just below the screw head where the screw head meets the screw shaft.The screws underwent fracture analysis.The returned devices were evaluated with optical microscopy and scanning electron microscopy.Analysis of images of the first screw showed that the fracture surface show sheared ductile dimples around the fracture surface with non-sheared dimples slightly off center.Fracture surface artifacts suggest a torsional overload failure mode.Semi-quantitative eds elemental analysis found the material consistent with ti-6al-4v titanium alloy.Analysis of images of the second screw showed that the fracture surface show sheared ductile dimples around the fracture surface with non-sheared dimples slightly off center.Fracture surface artifacts suggest the torsional overload failure mode.Semi-quantitative eds elemental analysis found the material consistent with ti-6al-4v titanium alloy.Medical records were not provided.Review of the device history records 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: TRAUMAONE 12MM CROSS DRIVE LOCKING SCREW
• Common Device Name: 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: 18563172
• Report Number: 0001032347-2024-00022
• Device Sequence Number: 6810747
• Product Code: JEY
• UDI-Device Identifier: 00888233000512
• UDI-Public: (01)00888233000512(10)65974347
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2024

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: 41-2412
• Device Lot Number: 65974347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 01/21/2024; 05/23/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/14/2024; 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Sex: Unknown