MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SAGITTAL SAW ATTACHMENT; ARTHROSCOPE

Catalog Number 4100400000

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure at the user facility elongated metal flakes fell off at patient side but could be removed completely.Nothing remained at patient site and no additional medical intervention was necessary.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.

Manufacturer Narrative

Product is not being returned to stryker for evaluation.The event for metal flakes was not confirmed as the device was not received for evaluation.

Event Description

It was reported that during a procedure at the user facility elongated metal flakes fell off at patient side but could be removed completely.Nothing remained at patient site and no additional medical intervention was necessary.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.

• Brand Name: SAGITTAL SAW ATTACHMENT
• 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: 5224990
• MDR Text Key: 31238329
• Report Number: 0001811755-2015-04140
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• 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
• Report Date: 10/19/2015

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: 4100400000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2014
• 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