MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PIN COLLET (2.0-3.2MM); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7203126000

Device Problem Biocompatibility (2886)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).One (1) event was reported for this quarter.One (1) device was available for evaluation but has not yet been received.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes one (1) malfunction event in which the device was reportedly received with a contaminant on the device.One (1) reported event had no patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale.1 previously reported event is included in this follow-up record.Product return status: 1 device was not available to stryker for evaluation. additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.Device not received for evaluation.

Event Description

This report summarizes 1 malfunction event in which the device was reportedly received with a contaminant on the device.1 reported event had no patient involvement; no patient impact.

• Brand Name: PIN COLLET (2.0-3.2MM)
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7220160
• MDR Text Key: 98450900
• Report Number: 0001811755-2018-00323
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

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: 7203126000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1