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 08/27/2014

Event Type  malfunction  

Event Description

It was reported that during service conducted at the manufacturer, the bur broke off in the driveshaft.There was no delay and no adverse consequences as a result of this event.

Manufacturer Narrative

The device was not returned to stryker instruments ireland.The quality investigation is complete.Device not returned to manufacturer.

Event Description

It was reported that during service conducted at the manufacturer the bur broke off in the driveshaft.There was no delay and no adverse consequences as a result of this event.

Manufacturer Narrative

The device has been returned.A follow up report will be filed once the quality investigation is complete.

• 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: 4110456
• MDR Text Key: 4933556
• Report Number: 0001811755-2014-03328
• 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: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• 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?: No
• Date Returned to Manufacturer: 08/26/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: (B)(4) LOT 0733709683; (B)(4) LOT 0733709683