MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM STERNALOCK BLU SEMI MODULAR TRAY; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Concomitant medical products - zimmer biomet screw catalog # unk lot #: unk.Report source - foreign county, (b)(6).
Event or Problem Description
It was reported that the screw block was placed in the tray backwards.As a result a larger screw than intended was implanted in the patient.The surgeon realized the issue and corrected the error during the same surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint cannot be verified.Functional testing and inspections could not be performed due to the product not being returned.The dhr will not be reviewed as the lot number remains unknown.There are no indications of manufacturing defects.For part 73-1300 in the previous one (1) year (from the notification date) regarding the screws being in backwards, there is a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.The most likely underlying 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.The following fields were updated: date of this report, describe event or problem, device availability, date received by manufacturer, type of report, follow up type, device evaluated by manufacturer, method code, results code, conclusions code, and additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: STERNALOCK BLU SYSTEM STERNALOCK BLU SEMI MODULAR TRAY
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9445303
• Report Number: 0001032347-2019-00553
• Device Sequence Number: 13959638
• Product Code: HRS
• UDI-Device Identifier: 00841036150006
• UDI-Public: 00841036150006
• Combination Product (Y/N): N
• PMA/510(K) Number: K110574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-1300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/10/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 04/20/2020
• 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: Required Intervention