MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEE H10; SCREW, FIXATION

Model Number N/A

Device Problems Difficult to Insert (1316); Migration (4003)

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

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

(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 following sections could not be completed as the part/lot information could be any of the following: brand name: lp non lock, catalog number: 131227210 , or brand name: lp non lock, catalog number: 131227211, or brand name: lp non lock , catalog number: 131227212, or brand name: lp non lock, catalog number: 131227213, or brand name: lp non lock, catalog number: 131227214, or brand name: lp non lock, catalog number: 131227220, or brand name: lp non lock, catalog number: 131227222, or brand name: lock screw square, catalog number: 131227114, or brand name: lock screw square, catalog number: 131227115, or brand name: lock screw square, catalog number: 131227116, or brand name: lock screw square, catalog number: 131227118.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05268, 0001822565 - 2019 - 05270, 0001822565 - 2019 - 05271, 0001822565 - 2019 - 05272, 0001822565 - 2019 - 05273, 0001822565 - 2019 - 05274, 0001822565 - 2019 - 05275, 0001822565 - 2019 - 05276, 0001822565 - 2019 - 05277, 0001822565 - 2019 - 05278, 0001822565 - 2019 - 05279.

Event Description

It was reported that the patient was undergoing a wrist fixation procedure.After implantation of the plate and screws, and running the wrist through range of motion, the plate/screw construct fell apart.Due to this, all reduction was lost, although some of the screws did stay in loosely.The surgeon wanted to start over with the same plate, but with different screws.Further, there were 3 screws that would not initially seat properly.The surgeon completed the procedure with the same plate and new screws.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information is available at the time of this report.

• Brand Name: SEE H10
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw 46582
• MDR Report Key: 9459147
• MDR Text Key: 173647598
• Report Number: 0001822565-2019-05269
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• PMA/PMN Number: K112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SEE H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention