MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL DRIVER SHAFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2107-1015

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

During a primary right hip when surgeon was implanting the screw into the shell, the threads wore down rendering the universal screwdriver no longer useable.During the same case, the surgeon had to remove the poly for adjustment and the threads on the poly were worn down rendering the device no longer useable.No delay or adverse consequence to the patient and the surgery completed without any other issues.

Manufacturer Narrative

An event regarding an damage (deformation) involving a universal driver shaft hexalobular screwdriver tip was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection revealed the hexalobular driver tip is deformed.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: a complaint history review confirmed there has been one other event for the lot referenced.Conclusions: visual inspection revealed the hexalobular driver tip is deformed.A capa investigation was completed and determined the failure mode is user related.This failure mode is observed when the driver is over torqued, the driver tip wears excessively due to repeated use of the driver, or when the driver tip is angulated extremely within the screw head during use.

Event Description

During a primary right hip when surgeon was implanting the screw into the shell, the threads wore down rendering the universal screwdriver no longer useable.During the same case, the surgeon had to remove the poly for adjustment and the threads on the poly were worn down rendering the device no longer useable.No delay or adverse consequence to the patient and the surgery completed without any other issues.

• Brand Name: UNIVERSAL DRIVER SHAFT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5454761
• MDR Text Key: 39222232
• Report Number: 0002249697-2016-00437
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2107-1015
• Device Lot Number: F10T94111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other