MAUDE Adverse Event Report: STRYKER GMBH STAR INSTRUMENTS KIT STERILE PACKAGED; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 1000071

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Debris found on single use instrument pack (b)(4) (outside and on instrument), which is likely to peel off from the red label.

Event Description

Debris found on single use instrument pack 100-0071 (outside and on instrument), which is likely to peel off from the red label.

Manufacturer Narrative

The reported event that star instruments kit sterile packaged was alleged of 'laser marking/printing fading/flaking' could be confirmed.Based on investigation, the root cause could have been caused by the contact of the steri-dot with "acetone", which is used as a cleaning agent during manufacturing.The device inspection revealed the following: the returned sterile inner pouches were returned and do indeed show some red debris all over them.It can be confirmed that the red debris are coming from the sterilization dots since the well-known red pattern of the gamma sign can be identified.

• Brand Name: STAR INSTRUMENTS KIT STERILE PACKAGED
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7907613
• MDR Text Key: 122009969
• Report Number: 0008031020-2018-00634
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385015767
• UDI-Public: 00886385015767
• Combination Product (y/n): N
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 1000071
• Device Lot Number: L14851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Date Manufacturer Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other