MAUDE Adverse Event Report: BIOMET MICROFIXATION "1.5MM" SYSTEM 1.5X6MM 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	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: item #91-6106, lot #j398520, "1.5mm" system 1.5x6mm ht sd x-dr scr qty 5; item #91-6107, lot #991620; "1.5mm" system 1.5x7mm ht sd x-dr scr ea.Initial report foreign source: colombia.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A definitive root cause cannot be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00374; 0001032347-2022-00375; 0001032347-2022-00376; 0001032347-2022-00378; 0001032347-2022-00379; 0001032347-2022-00380.
Event or Problem Description
It was reported that during a procedure that the screws fractured at the screw head when they were being implanted.This resulted in a delay in procedure of approximately 30 minutes.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: "1.5MM" SYSTEM 1.5X6MM 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: 15977491
• Report Number: 0001032347-2022-00377
• Device Sequence Number: 14917437
• Product Code: JEY
• UDI-Device Identifier: 00841036053758
• UDI-Public: (01)00841036053758(10)J398520
• 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
• Report Date (Section B): 12/09/2022

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: 91-6106
• Device Lot Number: J398520
• Was Device Available for Evaluation?: No
• 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: 11/05/2021
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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: 24 YR
• Patient Sex: Unknown