MAUDE Adverse Event Report: BIOMET TRAUMA ALPS SMALL FRAGMENT CORTICAL SCREW 3.5 X 16MM; PLATE, FIXATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Itching Sensation (1943)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Exact implant date is unknown, however, it occured sometime in (b)(6) 2008.Exact removal date is unknown, however, it occured sometime in (b)(6) 2009.Medical product- screw catalog#: 815341018 lot#:unk, screw catalog#: 815341020 lot#:unk, screw catalog#: 815037022 lot#unk, screw catalog#: 815540045 lot#:unk, plate catalog#: 814123005 lot#:unk, customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05014, 0001825034-2017-05013, 0001825034-2017-05015, 0001825034-2017-05016, 0001825034-2017-05017.

Event Description

It was reported patient underwent an initial ankle fracture plating procedure.Subsequently, the patient was revised approximately six (6) months post-operatively due to significant itching, a low-grade fever, and generally not feeling well.Patient is currently using a bone stimulator as treatment, and has not had the itching sensation since the product was removed.

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.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was patient condition as the patient had an allergic reaction to titanium.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

• Brand Name: ALPS SMALL FRAGMENT CORTICAL SCREW 3.5 X 16MM
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6724318
• MDR Text Key: 80401360
• Report Number: 0001825034-2017-05012
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 815037016
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 53