MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTO SCR 2.0X7MM 2.0 SYS 2/PK; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the surgeon used a 7mm screw after performing the drilling and tapping as usual, but could not fix the screw correctly.He then switched to an emergency screw, but it did not reach the planned position, and this emergency screw also failed to fixate correctly.Therefore, the surgeon decided to switch to a titanium plate to complete the surgery.
Additional Manufacturer Narrative
Complaint (b)(4).D10 ¿ medical products : item #915-2308-ea, lot #068090; lacto scr 2.5x7mm 2.0 sys 1pk.G3: foreign source: japan.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to update additional information in sections b4, b5, e1, e2, e3, g3, g6, h2, and h11.
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 records 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: LACTO SCR 2.0X7MM 2.0 SYS 2/PK
• Common Device Name: SCREW, FIXATION, 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: 21048208
• Report Number: 0001032347-2024-00414
• Device Sequence Number: 16996404
• Product Code: HWC
• UDI-Device Identifier: 00841036055028
• UDI-Public: (01)00841036055028(17)280428(10)66053354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002083
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2025

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: 915-2301
• Device Lot Number: 66053354
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 01/07/2025; 04/11/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/05/2025; 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown