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

Catalog Number 4100125000

Device Problem Metal Shedding Debris (1804)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).2 events were reported for this quarter.2 devices were received for evaluation; 2 events were confirmed during testing.1 device was found to have corrosion.1 device was found to be affected by metal shavings from a damaged component.The devices are not repairable and were not returned to the user facility.There were no remedial actions taken.The devices are not labeled for single-use.

Event Description

This report summarizes 2 malfunction events, in which the device was shedding metal debris.2 reported events 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6980813
• MDR Text Key: 91090317
• Report Number: 0001811755-2017-02145
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

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: No Information
• Device Catalogue Number: 4100125000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 10/26/2017
• 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