MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 12MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (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: 0001032347-2020-00496, 0001032347-2020-00497, 0001032347-2020-00498, 0001032347-2020-00500.Concimitant medical products: sternalock blu system plate, 8 hole x, part# 73-2623, lot# 855100.Sternalock blu system plate, 4 hole l-plate 100 degrees, part# 73-2643, lot# 562410.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 10mm, part# 73-2410, lot# 629330.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 12mm, part# 73-2412, lot# 629400.Sternalock blu system screw, cancellous cross-drive locking 2.4 x 14mm, part# 73-2414, lot# 630100.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported that the patient developed an infection twenty-three (23) days following implantation of sternal closure devices, and the devices were removed in a revision twenty-four (24) days following implantation of the devices.The doctors believe the devices are unlikely to be the cause of the infection due to the amount of time elapsed since implantation.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed because a revision surgery was reported.The devices were not returned for investigation and no photos, scans, x-rays, or physician's reports were provided.For these reasons, no functional testing or visual evaluations could be conducted.The dhr was reviewed and no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint regarding infection for this item# 73-2412, lot# 629400b.For this part (73-2412) in the previous one year (from the notification date), the full complaints history was reviewed and there is a complaint rate of 0.10%.Because this overall complaint rate is already below the occurrence rate of this failure mode, no further review is necessary.The most likely underlying cause of the complaint 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.The following fields were updated: b4 date of this report; b5 describe event or problem; 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 12MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10645017
• Report Number: 0001032347-2020-00499
• Device Sequence Number: 2604588
• Product Code: HRS
• UDI-Device Identifier: 00841036141141
• UDI-Public: 00841036141141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2412
• Device Lot Number: 629400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/27/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 01/08/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 55