MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STD BRL LAG SCRW 12.5X90MM; PROSTHESIS, TRAUMA

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2014

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).This report is being submitted late as it has been identified in remediation.Complaint sample was evaluated and the reported event was confirmed.The complaint was confirmed after review of packaging confirms opening of the inner sterile pouch.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Investigation results concluded that the reported event was due to shipping damage.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

It was reported that during a hip fracture procedure.The sales representative opened the package containing the lag screw and discovered that the inner sterile packaging was already opened.A biomet hiploc was used to complete the procedure with no delay or patient injury.No adverse events have been reported as a result of the malfunction.

• Brand Name: STD BRL LAG SCRW 12.5X90MM
• Type of Device: PROSTHESIS, TRAUMA
• 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: 6946198
• MDR Text Key: 90210262
• Report Number: 0001825034-2017-08611
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2017

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 Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 236090
• Device Lot Number: 1725567
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 10/12/2017
• 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