MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM PLATE, 8 HOLE JL-PLATE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2019
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.Concomitant medical products: unknown screws, part# unknown, lot# unknown.
Event or Problem Description
It was reported that a revision occurred for an unknown reason to remove an implanted plate and screws from a sternal fixation.Some of the screws fractured during removal.No additional patient consequences were 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.This complaint was opened as it was reported that these parts were removed in a revision and some of the screws fractured during explantation.As it was reported that these parts were removed in a revision, the complaint is considered confirmed.Three attempts were made to gather additional in regards to the reason for the revision.The distributor reported that the reason for the revision was unknown.No x-rays, scans, pictures, or physician¿s reports were provided.The distributor returned what was provided to them to zimmer biomet for evaluation.When product was received to distributor services, it was not associated with an rga number and therefore was not identified as complaint product and scrapped.Ie-10907 was opened to further investigate the scrapping of complaint product.As the product was not returned to complaints for evaluation, no functional tests or inspections could be performed.The dhr's of these products will not be reviewed due to the lot numbers remaining unknown.The complaint/sales history on the part #73-2645 will not be reviewed as there was nothing to indicate that the plate contributed to the screw fracture upon removal.The most likely underlying cause of the revision and broken screw could not be determined.There are no indications of manufacturing defects.There are no indications of manufacturing defects.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.

• Brand Name: STERNALOCK BLU SYSTEM PLATE, 8 HOLE JL-PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8968051
• Report Number: 0001032347-2019-00409
• Device Sequence Number: 2444533
• Product Code: HRS
• UDI-Device Identifier: 00841036141059
• UDI-Public: 00841036141059
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K011076
• 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): 01/15/2020

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: 73-2645
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention