MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0X7MM HT XDR LK-FRC SC; SCREW, FIXATION, 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	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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.Report source: (b)(6).
Event or Problem Description
It was reported that during surgical fixation, it was found that a screw tail cap in the fixation system was broken.One piece remains in patient and the other piece will be returned.There was no additional medical intervention for the patient and there was no surgical delay.
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 shows signs of attempted use.There is marking on the screw head.The screw shaft has fractured where it meets the screw head.The complaint is confirmed.A determination cannot be made as to what caused the screw shaft to fracture.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
No further event information is available at the time of this report.

• Brand Name: 2.0X7MM HT XDR LK-FRC SC
• 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: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12669675
• Report Number: 0001032347-2021-00492
• Device Sequence Number: 8506963
• Product Code: HWC
• UDI-Device Identifier: 00841036056667
• UDI-Public: (01)00841036056667
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/06/2021

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: 95-6105
• Device Lot Number: 023480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• 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: 09/21/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2020
• 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: 31 YR
• Patient Sex: Male