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 Twisted/Bent (2981); Mechanics Altered (2984)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The surgeon reported via the rep that a screwdriver from a trident set became twisted and could not engage with the screw correctly.There were no adverse events or delays related to this reported issue and that the surgery was completed as planned using an item from another kit.

Manufacturer Narrative

An event regarding damage (deformation) involving a trident driver shaft was reported.The event was confirmed.Visual inspection shows the hexalobular driver tip is deformed.The deformation of the tip indicates that it was damaged while the device being used to tighten a screw.Examination of the returned device with material analysis engineer indicated the damage observed is consistent with in-service use.Medical records received and evaluation: not performed as patient factors did not contribute to event.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been 1 other events for the lot referenced regarding damage to the hexalobular driver tip.Visual inspection confirms the reported event which shows that the hexalobular driver tip is deformed.The deformation of the tip indicates that it was damaged while the device being used to tighten a screw.The returned device was consulted with material analysis engineer, concluded that the damage observed is consistent with in-service use.

Event Description

The surgeon reported via the rep that a screwdriver from a trident set became twisted and could not engage with the screw correctly.There were no adverse events or delays related to this reported issue and that the surgery was completed as planned using an item from another kit.

• 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: 5930668
• MDR Text Key: 54485809
• Report Number: 0002249697-2016-02871
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• 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: F6K13658
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2011
• 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