MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MSP PROCEDURE KIT STERILE LEFT; FIXATION, PLATE

Model Number N/A

Device Problems Fracture (1260); Difficult to Insert (1316); Material Deformation (2976)

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

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical product: ms-ssr, msp procedure kit sterile right, 168401917b.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06556.

Event Description

It was reported that a driver broke twice.The surgeon drilled both cortical walls and began to insert the screw in the compression slot.While inserting the screw, the tip of the screw broke off.Subsequently, another set was opened for an additional driver.After the screw was fully inserted, the surgeon drilled again and the screw deformed the driver in a way that made it impossible for the surgeon to seat the screw.A third set was opened and the screw fully seated.There were no patient consequences as a result of the event.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as we do not have reporting responsibility for this device.The initial report was submitted in error and should be voided.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06556 - 1.

• Brand Name: MSP PROCEDURE KIT STERILE LEFT
• Type of Device: FIXATION, PLATE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6881908
• MDR Text Key: 87855442
• Report Number: 0001822565-2017-06557
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: MSSSL
• Device Lot Number: 168404817A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 55 YR