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

Model Number 4100062000

Device Problem Material Disintegration (1177)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2020

Event Type  malfunction  

Event Description

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

Event Description

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

Manufacturer Narrative

Follow-up report submitted to document device results.H3 other text : device not returned.

• Brand Name: WIRE COLLET
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10185588
• MDR Text Key: 196134459
• Report Number: 0001811755-2020-01538
• 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: 05/17/2021

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 Model Number: 4100062000
• Device Catalogue Number: 4100062000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1