MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI RM/LL TIB AUG SZ3 5MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5545-A-302
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant 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
This pi is for the intra-op event.During a revision of the patient's left knee, the tyvek of the outer and inner blisters each had a hole in them.No hole is visible on the outer box.The shrink rap was torn and discarded before discovery, there is no way to determine if there was a hole in the shrink wrap.Due to sterility concerns the device was not implanted.The rep opened both the outer and inner sterile blisters.Another device was obtained to complete the surgery successfully with a surgical delay of approximately 5 minutes while a tourniquet was in use.The device and packaging (except shrink wrap) are available for return.Rep reported that no further information will be available.
Additional Manufacturer Narrative
Reported event: an event regarding pack damage involving triathlon augment was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a the outer and inner blisters each had a hole in them.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the dimensional aspects are not in question.Material analysis: not performed as this event does not relate to material integrity.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the damage was visible in the photographs were provided for review.Based on the information provided, not concluded at what point the package was damaged and what was the exact cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
Event or Problem Description
This pi is for the intra-op event.During a revision of the patient's left knee, the tyvek of the outer and inner blisters each had a hole in them.No hole is visible on the outer box.The shrink rap was torn and discarded before discovery, there is no way to determine if there was a hole in the shrink wrap.Due to sterility concerns the device was not implanted.The rep opened both the outer and inner sterile blisters.Another device was obtained to complete the surgery successfully with a surgical delay of approximately 5 minutes while a tourniquet was in use.The device and packaging (except shrink wrap) are available for return.Rep reported that no further information will be available.

• Brand Name: TRI RM/LL TIB AUG SZ3 5MM
• 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: 9340691
• Report Number: 0002249697-2019-03817
• Device Sequence Number: 2145658
• Product Code: MBH
• UDI-Device Identifier: 07613327026399
• UDI-Public: 07613327026399
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/27/2020

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 Model Number: 5545-A-302
• Device Catalogue Number: 5545-A-302
• Device Lot Number: ERFFP9D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 02/29/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 03/27/2020
• 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
• Patient Age: 67 YR