MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK; PLATE, 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	08/14/2019
Type of Reportable Event	Malfunction
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.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 during surgery.No adverse events have been reported as a result of this malfunction.
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 cannot be verified.Functional testing and inspections could not be performed due to the product not being returned and no photographs being provided.The dhr will not be reviewed as the lot number remains unknown.There are no indications of manufacturing defects.For this part (95-6104) and the previous one year (from the notification date) regarding the fracturing of this screw, 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: 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: 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9405605
• Report Number: 0001032347-2019-00517
• Device Sequence Number: 2973082
• Product Code: JEY
• UDI-Device Identifier: 00841036056650
• UDI-Public: 00841036056650
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 95-6104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 03/20/2020
• 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