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 07/29/2016

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 service conducted at the manufacturer a broken bur was found inside 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

Bur breakage can be multifactorial: user applied side loading, bur exposure, running speed as well as attachment and drill conditions.The root cause is undetermined.

Event Description

It was reported that during service conducted at the manufacturer a broken bur was found inside 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.

• 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: 5908301
• MDR Text Key: 54146745
• Report Number: 0001811755-2016-02014
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNK_ICO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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