MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STRAIGHT SHAFT 6" TORX DRIVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2107-1017

Device Problems Device Inoperable (1663); Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that surgeon was doing a right hip revision (revision was not of stryker product) and surgeon used screwdrivers under power which cause devices to fail.No adverse consequence to patient or user and case completed without any complications.

Manufacturer Narrative

Corrected data: the device was not returned for evaluation.An event regarding an damage (deformation) involving a straight shaft 6" torx driver hexalobular screwdriver tip was reported.The event was confirmed.Method and results: device evaluation and results: the device was not returned.However, an image was provided of 2 drivers with no catalog and lot number.The image showed the hexalobular driver tips were damaged (twisted).Conclusions: the device was not returned.However, an image was provided of 2 drivers with no catalog and lot number.The image showed the hexalobular driver tips were damaged (twisted).

Event Description

It was reported that surgeon was doing a right hip revision (revision was not of stryker product) and surgeon used screwdrivers under power which cause devices to fail.No adverse consequence to patient or user and case completed without any complications.

• Brand Name: STRAIGHT SHAFT 6" TORX DRIVER
• 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: 5514552
• MDR Text Key: 41029141
• Report Number: 0002249697-2016-00946
• 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: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2107-1017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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