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

Catalog Number	1000071
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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 or Problem Description
Debris found on single use instrument pack 100-0071 (outside and on instrument), which is likely to peel off from the red label.
Additional 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7907613
• Report Number: 0008031020-2018-00634
• Device Sequence Number: 1399785
• Product Code: NTG
• UDI-Device Identifier: 00886385015767
• UDI-Public: 00886385015767
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other