MAUDE Adverse Event Report: BIOMET MICROFIXATION SCREW 2.0X10MM CROSS-DRIVE; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b(4).Foreign source: colombia.Provided photos of screw appears to have fractured at the base of the head of the screw near the thread area.No other determination can be made by the supplied photos.No product was returned; 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.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 is reported that during the placement of a screw for fixation of a trauma one plate, the ankle head fractured leaving the body inside the patient's bone and generating rearrangement of the plate for fixation in another area.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned screw.The screw head showed signs of attempted use including marking on the screw head.The screw shaft has fractured where the shaft meets the screw head.The complaint is confirmed.Measurements are unable to be completed due to screw head being used.A determination cannot be made as to what caused the screw to fracture.Additional information provided does not change the root cause of the previous investigation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: SCREW 2.0X10MM CROSS-DRIVE
• 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: 15988471
• Report Number: 0001032347-2022-00368
• Device Sequence Number: 20320893
• Product Code: JEY
• UDI-Device Identifier: 00888233000277
• UDI-Public: (01)00888233000277(10)J932820
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K081067
• 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
• Report Date (Section B): 01/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 41-2010
• Device Lot Number: J932820
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male