MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT

Catalog Number UNK_ICO

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

It was reported that the attachment was wobbling when the bur was inserted into the chuck.The devices were sent to another department for testing and it was noticed that the 2 burs used were bent.It was further reported that there was no patient impact and the procedure was completed successfully.

Manufacturer Narrative

The device is not available for return.A follow up report will be filed once the quality investigation is complete.Device discarded by customer.

Event Description

It was reported that the attachment was wobbling when the bur was inserted into the chuck.The devices were sent to another department for testing and it was noticed that the 2 burs used were bent.It was further reported that there was no patient impact and the procedure was completed successfully.

Manufacturer Narrative

The devices involved in this reported event were not returned for evaluation.Therefore the complaint could not be confirmed.A review of the associated handpiece's ifu list possible potential causes for the reported event as application of excessive pressure with the cutting accessory, the use of a damaged attachment, cutting accessory and/or handpiece, the use of the wrong size cutting accessory, or the cutting accessory extends too far from the distal end of the attachment or is not properly centered in the attachment.The quality investigation is complete.Device not returned to the manufacturer.

• 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: 3980776
• MDR Text Key: 17163063
• Report Number: 0001811755-2014-02794
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• 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?: 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 1304701073. UNK INS P/N, UNK LOT ID; UNKNOWN CHUCK UNKNOWN LOT; (B)(4) LOT 1304701073