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 Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; 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: 0001032347-2020-00119, 0001032347-2020-00176, 0001032347-2020-00177.Date of event was (b)(6) 2019.Explantation date was (b)(6) 2019 concomitant medical products: sternalock blu system plate, 8 hole x, part# 73-2623, lot# unk.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 12mm, part# 73-2412, lot# unk.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 14mm, part# 73-2414, lot# unk.
Event or Problem Description
It was reported a patient underwent a revision due to sternal plates and screws pulling through the sternum post-operatively.The failure of the sternal closure devices may have been due to trauma and patient non-compliance.No additional patient consequences have been reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed as a revision surgery was reported.Product was not returned for investigation and no photos, scans, x-rays, or physician's reports were provided.For these reasons, no visual inspections or functional testing could be conducted.The dhr could not be reviewed due to the lot number being unknown.There are no indications of manufacturing defects.For this part (73-2414) and the previous one year (from the notification date), the full complaints history was reviewed, and there is a complaint rate of (b)(4).The most likely underlying cause of the complaint is the patient's activity level post-op, due to the report that there was apparent trauma and possible patient non-compliance.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.The following fields were updated: b4 date of this report.B5 describe event or problem.D10 device availability.G4 date received by manufacturer.G7 type of report.H2 follow up type.H3 device evaluated by manufacturer.H6 method code.H6 results code.H6 conclusions code.H10 additional narratives/data.

• 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: 9849000
• Report Number: 0001032347-2020-00177
• Device Sequence Number: 16810192
• Product Code: HRS
• UDI-Device Identifier: 00841036141158
• UDI-Public: 00841036141158
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K110574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 01/06/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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