MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET; ARTHROSCOPE

Model Number 4100062000

Device Problem Material Disintegration (1177)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Event Description

The user facility reported that the device had metal shavings coming out during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Additional information: d9.

Event Description

The user facility reported that the device had metal shavings coming out during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: WIRE COLLET
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11088464
• MDR Text Key: 224092442
• Report Number: 0001811755-2020-03578
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540068354
• UDI-Public: 04546540068354
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4100062000
• Device Catalogue Number: 4100062000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1