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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.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 a screw fractured when locking into a sternal plate.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is that the screw fractured during insertion.Upon review of the returned product, it can be seen that the screw is fractured transversely.The complaint is confirmed.Functional testing could not be conducted due to the damaged condition of the screw.The most likely underlying cause of this complaint is excessive force, beyond what the screw is designed to encounter.There are no indications of manufacturing defects.(b)(4).The dhr of this product could not be reviewed due to the lot number being unknown.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 updated to reflect date of report.B5 updated to describe event or problem.D10 to reflect product return.G1-2 updated to reflect contact information.G4 date received by manufacturer.G7 updated to reflect type of report and follow-up number.H2 updated to reflect follow-up type.H3 updated to reflect device evaluated.H6 updated to reflect method, results, & conclusions.H10 updated to reflect additional narratives/data provided.
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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9375260
• Report Number: 0001032347-2019-00508
• Device Sequence Number: 2159385
• Product Code: HRS
• UDI-Device Identifier: 00841036141165
• UDI-Public: 00841036141165
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 73-2416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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