MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5521-B-600
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right knee.It was reported that the outer sterile blister would not peel back completely.The inner blister was attempted to be peeled back through the reduced opening, and in the process the device and the glove of an operating room staff member were rendered unsterile.Rep reported another device was obtained with no surgical delay as this occurred while a different part of the procedure was being performed that didn't depend on the device.Rep retained the device and packaging, and may be able to provide a usage sheet, but reported that x-rays, medical records, and additional information will not be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding a packaging issue involving a triathlon baseplate was reported.The event was confirmed.Method & results: device evaluation and results: the implant stickers and ifu, partially opened outer blister with its lid, and partially sealed inner blister with its contents were returned.The lid of the inner blister was stuck to the foam (see attached picture).Medical records received and evaluation: not performed as the event is not related to patient factors.-device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the reported event was confirmed.Visual inspection of the returned product indicated that the foam was stuck to the lid of the inner blister.A consultation with packaging smes resulted in the following conclusion: stryker orthopaedics currently utilizes a void filling approach to sterilize product packaging.Product is placed in the package and supported with foam of various sizes, and these configurations are then validated.The foam serves to protect both the product and the package, preventing the product from moving within the package and damaging the sterile barrier.As the purpose of the foam is to tightly constrain the product, the package configuration is designed to reduce open space.
Event or Problem Description
Primary procedure, right knee.It was reported that the outer sterile blister would not peel back completely.The inner blister was attempted to be peeled back through the reduced opening, and in the process the device and the glove of an o.R.Staff member were rendered unsterile.Rep reported another device was obtained with no surgical delay as this occurred while a different part of the procedure was being performed that didn't depend on the device.Rep retained the device and packaging, and may be able to provide a usage sheet, but reported that x-rays, medical records, and additional information will not be released by the hospital or surgeon.

• Brand Name: TRI TS BASEPLATE SIZE 6
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8304721
• Report Number: 0002249697-2019-00473
• Device Sequence Number: 13699536
• Product Code: MBH
• UDI-Device Identifier: 07613327026337
• UDI-Public: 07613327026337
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 11/30/2023
• Device Catalogue Number: 5521-B-600
• Device Lot Number: DG99AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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