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

Catalog Number 2030-6540-1

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 03/16/2015

Event Type  malfunction  

Event Description

It was reported that when nurse opened screw from its sterile packaging.It looked like that there were some debris on the threads of the screw.

Manufacturer Narrative

Additional information has been requested and if received will be provided in a supplemental report.Device not returned to manufacturer.

Manufacturer Narrative

Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided for review.If the device and/or additional information become available, this investigation will be reopened.

Event Description

It was reported that when nurse opened screw from its sterile packaging.It looked like that there were some debris on the threads of the screw.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 40MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NJ NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4685206
• MDR Text Key: 18037125
• Report Number: 0002249697-2015-01135
• Device Sequence Number: 1
• Product Code: HWC
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 2030-6540-1
• Device Lot Number: MNMALW
• Other Device ID Number: STERILE LOT# MSHNM22A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2014
• 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