MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PIN COLLET (2.0-3.2MM); ARTHROSCOPE

Catalog Number 4100125000

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 event was reported for this quarter.One 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 1 malfunction event in which the device disassembled.One reported event had no patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program.  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 disassembled.1 reported event had no patient involvement; no patient impact.

• Brand Name: PIN COLLET (2.0-3.2MM)
• 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7219277
• MDR Text Key: 98431572
• Report Number: 0001811755-2018-00079
• 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): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• 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: 4100125000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2017
• Was Device Evaluated by Manufacturer?: No
• 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