MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO THE MILL DISPOSABLE FINE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 5400702000

Device Problem Biocompatibility (2886)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2016

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility, the device had a white/gray deposit.The procedure was completed successfully, no medical intervention, and no adverse consequences reported.

Manufacturer Narrative

The reported condition was able to be confirmed, based on the product pictures provided by the sales rep.Presence of white particles was observed on the product.The inner surface of the lidstock (tyvek) could not be observed for evidence of friction (rubbing) between the device and the tyvek, due to the product not being returned.Product not returned by customer but pictures were provided.

Event Description

It was reported that during a surgical procedure at the user facility, the device had a white/gray deposit.The procedure was completed successfully, no medical intervention, and no adverse consequences reported.

• Brand Name: THE MILL DISPOSABLE FINE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5672731
• MDR Text Key: 45690665
• Report Number: 0001811755-2016-00739
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

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: 5400702000
• Device Lot Number: 15318012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1