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

Catalog Number 2107-1015

Device Problems Break (1069); Entrapment of Device (1212); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.

Event Description

Acetabular screwdriver tip broke in screw head.During a total hip procedure surgeon was unable to retrieve the screwdriver head.

Manufacturer Narrative

An event regarding crack/fracture involving a trident driver shaft was reported.The event was not confirmed.Device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: not performed as patient factors did not contribute to event.Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been 1 other events for this lot.The exact cause of the event could not be determined because insufficient information was provided.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Acetabular screwdriver tip broke in screw head.During a total hip procedure surgeon was unable to retrieve the screwdriver head.

• 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: 5880184
• MDR Text Key: 53047912
• Report Number: 0002249697-2016-02634
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• 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: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: F6A10840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2011
• 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