MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT

Catalog Number UNK_INS

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

It was reported that during testing by the operating room technician the bur broke off in the attachment.It was further reported that there was no associated procedure and therefore no patient involvement or adverse consequences as a result of this event.

Event Description

It was reported that during testing by the operating room technician the bur broke off in the attachment.It was further reported that there was no associated procedure and therefore no patient involvement or adverse consequences as a result of this event.

Manufacturer Narrative

An evaluation will be performed and a follow-up mdr will be submitted.

Manufacturer Narrative

Device evaluation completed.Quality investigation complete.

• Brand Name: UNKNOWN_INSTRUMENTS_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: 3669849
• MDR Text Key: 4342458
• Report Number: 0001811755-2014-00801
• Device Sequence Number: 1
• Product Code: JDZ
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2014

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: Health Professional
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 03/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2014
• 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
• Treatment: 5100010922 ATTACHMENT LOT #13191; 5100010922 LOT 13191