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 Consequences Or Impact To Patient (2199)

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Five events were reported for this quarter.Five devices were received for evaluation.Two events were confirmed.Three events were not duplicated; however, the devices were outside specifications.Four devices were found to be affected by corrosion.One device was found to have an accessory shedding debris within the device.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes malfunction events, in which the device was shedding metal debris.One event had patient involvement; no patient impact.Four 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7219279
• MDR Text Key: 98434428
• Report Number: 0001811755-2018-00078
• 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

• 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: 09/02/2017
• Initial Date FDA Received: 01/25/2018
• 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