MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-10-32F
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
The customer reported that two devices were opened and they were not clean inside.
Event or Problem Description
The customer reported that two devices were opened and they were not clean inside.
Additional Manufacturer Narrative
An event regarding glue reside on the inner blister involving a trident insert was reported.The event was confirmed by product inspection.Method & results: product evaluation and results: the inner blister was returned with the box and ifu however, the device and tyvek sheet was not returned.Residue is visible on the center of the lid of the inner blister.A material engineer indicated that the debris from the sample was consistent with tyvek.See attached materials engineering request document.Clinician review: not performed as medical records were not provided for review.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the event for glue residue on the inner blister was confirmed by product inspection.Residue is visible on the center of the lid of the inner blister.A material engineer indicated that the debris from the sample was consistent with tyvek.Product surveillance will continue to monitor for trends.Corrective action/preventive action: nc was created for tyvek sheet residue on inner blister lid.The nc noted, ¿the retainer within the inner sealed blister showed a white residue which is characterized as a glue-like substance (tyvek residue) on the retainer.The quality monitoring and post market surveillance team completed a fourier-transform infrared spectroscopy (ftir) test and confirmed that the substance is coming from the tyvek.The white substance is fixed on the retainer (no loose particulates) and, therefore, no substance would be in contact with the implant.The visual defect also does not affect the integrity of the sterile barrier system (sbs).Therefore, the sbs still meets its intent from a seal strength and seal integrity perspective and maintains the product sterility within the package.In the event that the sealing process creates this glue-like substance defect on the retainer, this defect would be even more noticeable by the or staff once the inner blister was opened.Per ifu (b)(4), ¿the packaging of all sterile products should be inspected for flaws in the sterile barrier before opening.In the presence of such a flaw, the product must be assumed nonsterile.¿ per complaint this defect created a delay to surgery of 20 minutes.Therefore, the highest potential severity of harm is s1.¿.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7450491
• Report Number: 0002249697-2018-01194
• Device Sequence Number: 1642714
• Product Code: LPH
• UDI-Device Identifier: 07613327039863
• UDI-Public: 07613327039863
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K033716
• 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): 01/03/2019

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: 11/30/2022
• Device Catalogue Number: 623-10-32F
• Device Lot Number: P4421J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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