MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT

Catalog Number UNK_ICO

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during testing, prior to surgery, the router broke in the attachment.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.

Manufacturer Narrative

New information was provided that the broken router was used in a laboratory environment and was reprocessed by the customer.The customer confirmed that the router was only used in a laboratory setting and was not used on a patient.

Event Description

It was initially reported that during testing, prior to surgery, the router broke in the attachment.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.It was subsequently reported that the broken router was used in a laboratory environment and was reprocessed by the customer.The customer confirmed that the router was only used in a laboratory setting and was not used on a patient.

Manufacturer Narrative

The router subject to this investigation was returned to the manufacturer for evaluation.It was visually confirmed that the router was broken.The returned router was measured where possible and all critical specifications were met.It was reported in this event that the router was being used in a laboratory setting and there is no report of adverse consequences, patient involvement or surgical procedure.It was also reported that the device was reused.This product is labeled for single use only.

Event Description

It was initially reported that during testing, prior to surgery, the router broke in the attachment.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.It was subsequently reported that the broken router was used in a laboratory environment and was reprocessed by the customer.The customer confirmed that the router was only used in a laboratory setting and was not used on a patient.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: UNKNOWN
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: dervillia murphy ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 5366137
• MDR Text Key: 36350344
• Report Number: 0001811755-2016-00056
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2015

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_ICO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/29/2016; 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1