MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TRAUMA NAIL; FIXATION

Catalog Number UNKNOWN TRAUMA

Device Problem Insufficient Information (3190)

Patient Problem Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint- (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.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.This report is being submitted late as it has been identified in remediation.

Event Description

Information was received based on review of a journal article titled, "flexible interlocked nailing of pediatric femoral fractures: experience with a new flexible interlocking intramedullary nail compared with other fixation procedures" which aimed to investigate outcomes associated with fixation of femoral shaft fractures in children and adolescents using the flexible interlocking intramedullary nail (fiin) (pediatric locking nail manufactured at biomet) as compared to other fixation procedures (ofp).The journal article reported that at the final follow-up, the (b)(6) contained one (1) patient had a heterotopic ossification.

• Brand Name: UNKNOWN TRAUMA NAIL
• Type of Device: FIXATION
• 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: 7116862
• MDR Text Key: 94819619
• Report Number: 0001825034-2017-11185
• Device Sequence Number: 1
• Product Code: HSB
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN TRAUMA
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• 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