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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the fixation of the bone flap, the screw that was being placed to fix the double plate fractured.The body of the screw was removed, and the position was changed to procedure with fixation.It was reported that no further information is available.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).G3: foreign: colombia.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.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.

• Brand Name: 1.5MM SYSTEM 1.5X5MM HT SD 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: 18650561
• Report Number: 0001032347-2024-00049
• Device Sequence Number: 18190737
• Product Code: JEY
• UDI-Device Identifier: 00841036053741
• UDI-Public: (01)00841036053741(10)J66222936
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121589
• 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): 06/07/2024

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: 91-6105
• Device Lot Number: J66222936
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 03/12/2024; 05/23/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/26/2024; 06/07/2024
• Date Device Manufactured: 06/24/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Unknown