MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; BUR, DENTAL

Catalog Number UNK_ICO

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2017

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 set up, a broken bur was found inside the core impaction drill.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

Investigation results indicate that issues with the associated handpiece drill (5400300000, sn (b)(4)) potentially caused the bur to break.Through visual inspection of the handpiece drill, the driveshaft assembly was corroded.

Event Description

It was reported that during set up, a broken bur was found inside the core impaction drill.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: BUR, DENTAL
• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 6716637
• MDR Text Key: 80122999
• Report Number: 0001811755-2017-01387
• Device Sequence Number: 1
• Product Code: EJL
• 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: 08/23/2017

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: 07/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/17/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 08/23/2017
• 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: 5400300000, SN (B)(4)