MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORDLESS DRIVER 3 HANDPIECE; ARTHROSCOPE

Catalog Number 4300000000

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One event was reported for this quarter.One device was received for evaluation; one event was confirmed.One device was found to be affected by disassembly due to wear.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 1 malfunction event in which the device disassembled.One reported event had no patient involvement; no patient impact.

• Brand Name: CORDLESS DRIVER 3 HANDPIECE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7219282
• MDR Text Key: 98434883
• Report Number: 0001811755-2018-00066
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4300000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1