MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 40MM; SCREW, FIXATION, BONE

Catalog Number 2030-6540-1

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

An event regarding a packaging issue involving a bone screw was reported.The event was confirmed.Device evaluation and results: the device and its packaging were not returned.However, an image was provided showing the packaging box with a torn opening flap and an ifu, without the blister pack and the implant.No medical records were received for review with a clinical consultant.No adverse consequences to the patient were noted.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.The reported event was found to be a nonconformance.The potential root cause is more of a human error as the part and blister assembly are required to be visually inspected during the contents to box and sealing operation.This is an isolated occurrence.Not returned.

Event Description

It was reported that the torx cancellous bone screw box was opened and found to contain no blister pack nor was there a screw.The container had the original plastic wrap on it.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 40MM
• Type of Device: SCREW, FIXATION, BONE
• 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: bradley curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7278408
• MDR Text Key: 100469606
• Report Number: 0002249697-2018-00471
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327037029
• UDI-Public: 07613327037029
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K894124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 2030-6540-1
• Device Lot Number: TV6Y30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other