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 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Thirteen devices were received for evaluation; 10 events were confirmed during testing.Five devices were found to have corrosion.Four devices were found to have shattered bearings.One device was found to be affected by metal shavings from a pin.The reported event was not confirmed for 3 devices; the devices were found to be within specifications for the reported event.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 thirteen malfunction events, in which the device was shedding metal debris.Three reported events had no patient involvement; no patient impact.Ten reported events had patient involvement with 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: 6526415
• MDR Text Key: 74148719
• Report Number: 0001811755-2017-01144
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 13
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2017

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: 12/02/2016
• Initial Date FDA Received: 04/27/2017
• 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