MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET; ARTHROSCOPE

Catalog Number 4100062000

Device Problems Disassembly (1168); Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

Event Type  malfunction  

Event Description

It was reported that during testing during a procedure at the user facility the device was producing metal particles.The procedure was completed without a clinically significant delay; no medical intervention or adverse consequences were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during testing during a procedure at the user facility the device was producing metal particles.The procedure was completed without a clinically significant delay; no medical intervention or adverse consequences were reported.It was also reported that during testing conducted at the manufacturer facility the device was missing the bearings.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported with this event.

Manufacturer Narrative

The service technician confirmed the reported event.Upon disassembly, the technician noted a lack of lubrication in the ball retention assembly.The device was scrapped by stryker.

Event Description

It was reported that during testing during a procedure at the user facility the device was producing metal particles.The procedure was completed without a clinically significant delay; no medical intervention or adverse consequences were reported.It was also reported that during testing conducted at the manufacturer facility the device was missing the bearings.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported with this event.

• Brand Name: WIRE COLLET
• 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: 5318788
• MDR Text Key: 34130725
• Report Number: 0001811755-2015-04723
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K943323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2015

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: Health Professional
• Device Catalogue Number: 4100062000
• Device Lot Number: 09026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2016; 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/1990
• 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