MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number UNK_SPN

Device Problems Contamination (1120); Material Fragmentation (1261); Residue After Decontamination (2325)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/14/2016

Event Type  malfunction  

Event Description

It was reported that an instrument tray was contaminated.This was noticed in neuro theatres while the scrub nurse was changing the screw driver shaft after debris had fallen out into the sterile field.The debris was removed and placed in a plastic tube before sending for the protein by the customer to their own lab.

Manufacturer Narrative

Method: risk assessment; results: manufacturing records could not be reviewed as no lot # was provided.No device was received back for inspection.Conclusion: no further investigation for this event is possible at this time as no devices and insufficient information was received.

Event Description

It was reported that an instrument tray was contaminated.This was noticed in neuro theatres while the scrub nurse was changing the screw driver shaft after debris had fallen out into the sterile field.The debris was removed and placed in a plastic tube before sending for the protein by the customer to their own lab.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6427523
• MDR Text Key: 70907886
• Report Number: 0009617544-2017-00112
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

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: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2017
• 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