MAUDE Adverse Event Report: ZIMMER INC. ZIMMER STEM INSERTER; DRIVER, PROSTHESIS

Catalog Number 00771205600

Device Problems Use of Device Problem (1670); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 10/07/2013

Event Type  malfunction  

Manufacturer Narrative

Information was received from a surgeon who is not required to complete form 3500a.Visual inspection determined that the device exhibits significant wear and damage indicative of extensive use in the field, thus demonstrating the device was used effectively prior to the submission of this complaint.The device has a potential field age of approximately 7.5 years.A hardness reading of the returned device indicates the hardness is within print specifications.A functional examination of the device shows that the actuating tip within the teardrop feature does not effectively protrude.The actuating tip does not protrude sufficiently due to interference between the tip and the main body of the device.The locking mechanism of the slider pin is frozen in the inserter frame, causing the mechanism of the device to be ineffective.This interference is caused by mechanical damage to both the tip and the body.The device was used for treatment.The exact cause of this damage cannot be determined.It is likely a combination of normal wear and tear and incidental damage caused by impaction during use.Based on the nature of the failure, the potential field age of the device, and the evidence of prior effective use, no product issues are identified as a result of this reported event.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported that the surgical technician was unable to lock the stem onto the inserter.

• Brand Name: ZIMMER STEM INSERTER
• Type of Device: DRIVER, PROSTHESIS
• Manufacturer (Section D): ZIMMER INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw,, IN 46581
• MDR Report Key: 5557056
• MDR Text Key: 42154838
• Report Number: 1822565-2016-00908
• Device Sequence Number: 1
• Product Code: HWR
• 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: 10/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00771205600
• Device Lot Number: 60450588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2013
• Date Device Manufactured: 04/01/2006
• 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