MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #3 PS INSERT 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5532P311
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Damaged sterile barrier was found when the nurse opened the outer box to use the device.
Additional Manufacturer Narrative
An event regarding damage to the sterile barrier involving a triathlon insert was reported.The event was confirmed by visual inspection.Device evaluation and results: four unit cartons were returned for evaluation.Two unit cartons were complete with shrink wrap.Two unit carton had their shrink wrap removed.One unit carton with the shrink wrap removed contained the outer blister unopened with the inner blister inside.The blister and the lid appear unremarkable.One unit carton contained an outer blister with its lid removed on three sides.There is an unopened inner blister inside the opened outer blister.The inner blister appears unremarkable.The two returned unit carton with the shrink wrap removed appear to be slightly bulged/swollen at the back.Medical records received and evaluation: not performed as no medical records were provided.Device history review: all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been three other similar events for the lot referenced.All four events are reported within this pi.Conclusions: based on the visual inspection and the information provided, the investigation resulted in an nc being initiated to further investigate the identified packaging nonconformance.Nc investigation results indicated that the reported product was not manufactured per specifications and that the defect occurred due to inadequate sealing of the outer blister.Nc was closed (b)(6) 2017.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Damaged sterile barrier was found when the nurse opened the outer box to use the device.

• Brand Name: TRIATHLON #3 PS INSERT 11MM
• 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: 6703143
• Report Number: 0002249697-2017-02165
• Device Sequence Number: 1509045
• Product Code: MBH
• UDI-Device Identifier: 07613327042665
• UDI-Public: 07613327042665
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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: 12/16/2021
• Device Catalogue Number: 5532P311
• Device Lot Number: LFM082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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