MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI RM/LL TIB AUG SZ4 10MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5546-A-402
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2018
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 reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
After opening the undamaged implant plastic and cardboard box the scout noticed the top layer of paper on the first sterile plastic container was perforated, the next layer was also perforated and hence the implant was deemed unsterile and not used.There were no adverse consequences as there was an identical implant on the loan set.
Additional Manufacturer Narrative
An event regarding packaging issue involving a triathlon augment was reported.The event was confirmed by provided images.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicates 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 small hole in the inner and outer tyvek lids was confirmed but the root cause not determined.It was confirmed by the provided images which showed a small hole in the inner and outer tyvek lids.The device was not used in this surgery and another device was available for implantation.The packaging will not be returned as it has been discarded by the hospital.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
After opening the undamaged implant plastic and cardboard box the scout noticed the top layer of paper on the first sterile plastic container was perforated, the next layer was also perforated and hence the implant was deemed unsterile and not used.There were no adverse consequences as there was an identical implant on the loan set.

• Brand Name: TRI RM/LL TIB AUG SZ4 10MM
• 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: 7363265
• Report Number: 0002249697-2018-00849
• Device Sequence Number: 11081207
• Product Code: MBH
• UDI-Device Identifier: 07613327026214
• UDI-Public: 07613327026214
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 08/31/2021
• Device Catalogue Number: 5546-A-402
• Device Lot Number: ERAWN7D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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
• Patient Age: 79 YR