MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS X-DRIVE LOCKING 5 PACK 2.4 X 14MM; PLATE, 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	04/30/2021
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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00272.Concomitant medical products: sternalock blu system screw, cancellous x-drive locking 5 pack 2.4 x 12mm, part# 73-5412, lot# 796100, sternalock blu system plate, 8 hole x, part# 73-2623, lot# 494070.Foreign: (b)(6).
Event or Problem Description
It was reported that two (2) screws fractured upon insertion during a sternal closure procedure.While the surgeon was inserting the screw, the screw fractured through the plate and entered a third of the depth of the sternum.The screw fragment was removed from the patient with forceps and the position of the hole was moved.Another screw insertion was attempted and the second screw fractured.The sternum was closed with cerclage wire.A surgical delay of 20 minutes was reported.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Quantity of one screw 2.4x12mm cancellous 5pk and one screw 2.4x14mm cancellous 5pk were returned for evaluation.Visual examination identified each screw being fractured into two pieces.Review of the device history records 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 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: STERNALOCK BLU SYSTEM SCREW, CANCELLOUS X-DRIVE LOCKING 5 PACK 2.4 X 14MM
• Common Device Name: PLATE, 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 11855491
• Report Number: 0001032347-2021-00272
• Device Sequence Number: 17000480
• Product Code: HRS
• UDI-Device Identifier: 00841036141202
• UDI-Public: (01)00841036141202(10)865960
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110574
• 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): 11/18/2021

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: 73-5414
• Device Lot Number: 565960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• 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: 05/07/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Sex: Male