MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X5MM HT X-DR SCR; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported, that the patient underwent a procedure.And subsequently was revised for an unknown reason.Attempts have been made.And additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Concomitant medical products: item # 01-6482, lot #: 161370, 1.5/0.6 2mm lefort plate; qty 2.Item # 95-1805, lot #: 273127f, 1.8x5mm ht x-dr screw.Item # 95-1505, lot #: 273727f, 1.5x5mm ht x-dr screw; qty 21.G2: foreign: japan.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: 0001032347-2023-00237, 0001032347-2023-00238, 0001032347-2023-00239, 0001032347-2023-00240, 0001032347-2023-00241, 0001032347-2023-00242, 0001032347-2023-00243, 0001032347-2023-00244, 0001032347-2023-00245, 0001032347-2023-00246, 0001032347-2023-00247, 0001032347-2023-00248, 0001032347-2023-00249, 0001032347-2023-00250, 0001032347-2023-00251, 0001032347-2023-00252, 0001032347-2023-00253, 0001032347-2023-00254, 0001032347-2023-00256, 0001032347-2023-00257, 0001032347-2023-00258, 0001032347-2023-00259, 0001032347-2023-00260.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D4: the previously reported lot number was determined to be incorrect by inventory transaction history.Therefore, it is being changed to unknown.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Review of customer-provided photos shows fractures of two plates.No defects could be confirmed on the photos of the 22 reported screws.As the reason for revision is unknown, no conclusions can be made by these photos.Lot identification is necessary for review of device history records, lot identification was not provided for the screws.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is 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 plates and screws.Both plates and the screws show signs of attempted use including marking and scratching on the product surfaces.Both plates have fractured.The returned devices were evaluated with optical microscopy and scanning electron microscopy.Sem images of the fracture surfaces of the two plates show fatigue striations, suggesting the fatigue failure mode.Semi quantitative eds elemental analysis found the material to be consistent with titanium with minor carbon contamination.For the (b)(4) returned screws all screws show signs of light use with minor marking on the screw surfaces.All screws however are intact with no signs of damage.The screws are fully functional with no issues found.A definitive root cause cannot be determined.The reported event is confirmed, based on product return.This report is being submitted to update additional information in sections b4, b5, d9, g3, g6, h2, h3, h6, and h11.

• Brand Name: 1.5X5MM HT X-DR SCR
• Common Device Name: PLATE, BONE
• 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: 17172227
• Report Number: 0001032347-2023-00255
• Device Sequence Number: 12551267
• Product Code: JEY
• UDI-Device Identifier: 00841036056162
• UDI-Public: (01)00841036056162
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 95-1505
• Device Lot Number: 273727F
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 10/11/2023; 08/21/2024
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 09/27/2023; 10/19/2023; 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown