MAUDE Adverse Event Report: ZIMMER INC MIS INSTRUMENTATION LATERAL ALIGNMENT FRAME; HTR

Catalog Number 00780701502

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Returned for review is a lateral alignment frame.As returned, the thumb screw is fractured where the shaft meets the knob.The o-ring is not returned.The diameter of the shaft is conforming to print specifications, and the material hardness is within print specifications.This device was used for treatment.The device was manufactured in october of 2013 and has a potential field age of 16 months.No additional complaints have been received against this manufacturing lot.The thumb screw is intended to be used as a secondary locking mechanism after the dovetail feature.A definitive cause cannot be determined.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It is reported that the thumb screw of the alignment guide broke.

• Brand Name: MIS INSTRUMENTATION LATERAL ALIGNMENT FRAME
• Type of Device: HTR
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5572007
• MDR Text Key: 42992338
• Report Number: 1822565-2016-01194
• Device Sequence Number: 1
• Product Code: HTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00780701502
• Device Lot Number: 62514818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1