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

Catalog Number	2030-6540-1
Medical Device Problem Codes	Component Missing (2306); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7278408
• Report Number: 0002249697-2018-00471
• Device Sequence Number: 14015418
• Product Code: HWC
• UDI-Device Identifier: 07613327037029
• UDI-Public: 07613327037029
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 2030-6540-1
• Device Lot Number: TV6Y30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other