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

Catalog Number 2107-1015

Device Problem Bent (1059)

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

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.

Event Description

It was reported, "the acetabulum screw driver bent.".

Manufacturer Narrative

Reported event: an event regarding an damage (deformation) involving a universal driver shaft hexalobular screwdriver tip was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no items were returned.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 have been (b)(4) other events for the lot referenced.Conclusions: event could not be confirmed as the reported device was not returned for evaluation.Capa (b)(4) previously investigated similar events and concluded the applying excessive torque to the driver and over-angulation during use leads to wear and damage of the driver tip.Ecn (b)(4) was implemented on (b)(6) 2005 to improve the fit of the driver tip and screw head and reduce the likelihood of driver tip deformation.The design intent of the driver tip is to deform rather than to deform and/or break the screw (implant).

Event Description

It was reported, "the acetabulum screw driver bent.".

• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5667656
• MDR Text Key: 45625284
• Report Number: 0002249697-2016-01655
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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