MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532-G-309
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Surgeon's preference is to hold the poly until the cement has hardened.All surgical staff are in stryker hoods & helmets, at all times.The tibial insert was confirmed by the surgeon.Inner, sterile, package delivered to the field appropriately by the circulating rn.Inner package remained intact until he opened it.Surgeon proclaimed, "there is a hair on the insert." i was then shown the insert.On the anterior aspect of the poly, near the retention wire was a hair.I responded with, "please, pass the insert off the field.I will get another." insert was placed in a specimen container.Which was subsequently returned to the original packaging, along with the remaining stickers.
Additional Manufacturer Narrative
An event regarding a hair found in the packaging involving a triathlon insert was reported.The event was confirmed.Conclusions the reported event was confirmed and the root cause was determined to be a manufacturing non-conformance.Nc raised on 20-jul-2018 regarding the stray hair found on the implant and to define the root cause and corrective actions.Corrective action/preventive action: it was concluded that the stray hair had no effect on the quality, functionality, or sterility of the implant.The product was not used in surgery and a backup unit was immediately available for implant, causing only a five (5) minute delay to surgery.There is nothing in the packaging process that would inherently cause the hair to reoccur on each piece of the lot.Therefore, we are confident that the scope can be restricted to just this one piece.This is based on the 100% verification of each product individually, proper gowning procedures in the packaging areas, and the independent sealing process within the room.In addition, (b)(4) allows for an occurrence of foreign material within the blister of 1 in 5,000 parts, which is well within the expected rates of manufacturing.
Event or Problem Description
Surgeon's preference is to hold the poly until the cement has hardened.All surgical staff are in stryker hoods & helmets, at all times.The tibial insert was confirmed by the surgeon.Inner, sterile, package delivered to the field appropriately by the circulating rn.Inner package remained intact until he opened it.Surgeon proclaimed, "there is a hair on the insert." i was then shown the insert.On the anterior aspect of the poly, near the retention wire was a hair.I responded with, "please, pass the insert off the field.I will get another." insert was placed in a specimen container.Which was subsequently returned to the original packaging, along with the remaining stickers.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7675517
• Report Number: 0002249697-2018-02120
• Device Sequence Number: 13798941
• Product Code: MBH
• UDI-Device Identifier: 07613327050646
• UDI-Public: 07613327050646
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/27/2018

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: 02/28/2023
• Device Catalogue Number: 5532-G-309
• Device Lot Number: 9V2Y5W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/27/2018
• 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