MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK 1.5MM X 5MM; PLATE, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Initial reporter occupation - distributor on behalf of facility.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (b)(6).

Event Description

It was reported a screw head broke during surgery.Attempts have been made and no further information has been provided.

Event Description

This follow-up report is being submitted to relay additional information.

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 and occurrence rate of this lot will not be reviewed as the lot number remains unknown.There are no indications of manufacturing defects.For this part (95-6105) and the previous one year (from the notification date) regarding the fracturing of this screw, there is a complaint rate of 0.03% 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.

• Brand Name: 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK 1.5MM X 5MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10686788
• MDR Text Key: 214805271
• Report Number: 0001032347-2020-00513
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036056667
• UDI-Public: 00841036056667
• Combination Product (y/n): N
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 95-6105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1