MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 14MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00368, 0001032347-2020-00369, 0001032347-2020-00370, 0001032347-2020-00371.Medical products: sternalock 360 multi-implant system, part# 74-0004, lot# 065990.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 14 mm, part# 73-2414, lot# ni.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 16 mm, part# 73-2416, lot# ni.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 18 mm, part# 73-2418, lot# ni.
Event or Problem Description
It was reported the patient experienced a sternal dehiscence six (6) days following implantation of sternal closure devices.A post-operative ct scan revealed that the screws had backed out of the manubrium and bottom plates while the center x plate had broken in half.The surgeon asserts that the screw depth was correctly measured and the devices were implanted correctly.The surgeon believes that the patient¿s cough contributed to the device failure.The sternal closure devices were explanted seven (7) days following implantation.No additional patient consequences have been reported.
Event or Problem Description
No further event information available at the time of this report.
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.Lot identification is necessary for review of device history records; lot identification was not provided for the screws.The doctor reported the plate broke and screws ripped out due to the patient¿s cough; however, 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.

• Brand Name: STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 14MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10391410
• Report Number: 0001032347-2020-00369
• Device Sequence Number: 3668926
• Product Code: HRS
• UDI-Device Identifier: 00841036141158
• UDI-Public: 00841036141158
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 73-2414
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention