MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X5MM HT SD X-DR SCR EA; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Catalog Number	91-6105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 1.5x5mm ht sd x-dr scr ea cat#91-6105 lot#j66634520.G2: 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
It was reported that 2 screws were fractured during the placement of bone flap.Additional information is not available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d4 d10; g1; g3; g6; h1; h2; h3; h4; h6; h10.The reported event is confirmed, based on product return.A visual inspection was conducted on the returned screws.The screw shows signs of attempted use including marking and scratching on the screw surfaces.Further inspection shows that the screws have fractured.The screw tips were not returned.The product was sent for fracture analysis.The returned cross drive screw was examined using optical microscopy and scanning electron microscopy.Most of the fracture surface is obscured by debris, thus making it difficult to analyze the mode of failure.However, suspected ductile dimples identified near the edge of the fracture adjacent to the debris, indicative of possible overload mode of failure.Analysis was only conducted on one screw as failure mode is consistent on screws tested in other returns from this customer for this part number.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.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.
Event or Problem Description
It was reported that during an initial procedure involving the placement of the bone flap, the screws fractured.The proper surgical technique was used.The fractured screw parts were removed from the patient, and the procedures were completed successfully using alternative devices.Attempts have been made, and no further information has been provided.

• Brand Name: 1.5X5MM HT SD X-DR SCR EA
• Common Device Name: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
• 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: 20461684
• Report Number: 0001032347-2024-00319
• Device Sequence Number: 20774773
• Product Code: JEY
• UDI-Device Identifier: 00841036053741
• UDI-Public: (01)00841036053741(10)J66634520
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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 Catalogue Number: 91-6105
• Device Lot Number: J66634520
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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
• Patient Age: 58 YR
• Patient Sex: Male