MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT

Catalog Number UNK_ICO

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device discarded by customer.

Event Description

It was reported that during a osteotomy that the blade broke at the cutting end/teeth.It was also reported that there was a 5 minute delay to replace the blade and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

The quality investigation is complete.

Event Description

It was reported that during a osteotomy that the blade broke at the cutting end/teeth.It was also reported that there was a 5 minute delay to replace the blade and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• 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: 5942340
• MDR Text Key: 54792167
• Report Number: 0001811755-2016-02165
• Device Sequence Number: 1
• Product Code: DWI
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ICO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• 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