MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/4" INCH KEYLESS DRILL CHUCK; ARTHROSCOPE

Catalog Number 4100133000

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2018

Event Type  malfunction  

Event Description

It was reported that during testing the washer came off of the device.There was no adverse consequences associated with this event.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

It was reported that during testing the washer came off of the device.There was no adverse consequences associated with this event.

• Brand Name: 1/4" INCH KEYLESS DRILL CHUCK
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7614123
• MDR Text Key: 111512755
• Report Number: 0001811755-2018-01074
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540377999
• UDI-Public: 04546540377999
• Combination Product (y/n): N
• PMA/PMN Number: K943323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4100133000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1