MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; BIT, SURGICAL

Catalog Number UNK_ICO

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting device return.

Event Description

It was reported via the customer that the drill broke in the attachment during testing.It was further reported that there was no associated procedure.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

It was confirmed that the drill bit that broke was not a stryker device.The quality investigation is complete.Device not returned.

Event Description

It was reported via the customer that the drill broke in the attachment during testing.It was further reported that there was no associated procedure.It was also reported that there were no delays 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: BIT, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8753117
• MDR Text Key: 149789442
• Report Number: 0001811755-2019-02182
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

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_ICO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4100355000, RADIOLUCENT RGT ANGLE DR, S/N UNKNOWN; 4100355000, RADIOLUCENT RGT ANGLE DR, S/N UNKNOWN