MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIDENT TRITANIUM ALIGNMENT GUIDE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	I-H2022AG00
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been one other event for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
After receiving two custom made instruments, we removed them from the packaging and reviewed the instrument before showing the physician.When putting the guide on the inserter we noticed something did not seem correct.I had contacted the rep from the customs instruments decision and sent pictures to see if something was done incorrectly.After sending pictures and the product number stephen noticed that the pin on the modular sleeve is protruding out the wrong side rotating everything 180 degrees in the wrong direction.
Additional Manufacturer Narrative
An event regarding an assembly issue (pin on the modular sleeve protruding out the wrong side) involving a trident guide was reported.The event was confirmed based on evaluation of returned device.Method & results: -device evaluation and results: visual inspection: the device was returned for evaluation.Based on visual inspection, it is confirmed that the pin on the modular sleeve is protruding on the wrong side.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: upon assembly of the specialty trident tritanium alignment guide, i-h2022ag00, the incorrect pin orientation of the modular sleeve assembly i-h2022sa00 caused the modular pointer assembly p/n: (b)(4) (specialty tritanium / trident modular pointer assembly) to point 180 degrees in the incorrect direction.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 has been one complaint for the reported lot.Assenssment: according to the complaint, when the stryker sales representative received the two specialty alignment guides that were ordered, they ¿¿ removed the from the packaging and reviewed the instrument before showing the surgeon¿.It was during this review, outside of the hospital environment, that the sales representative discovered the discrepancy.The two i-h2022ag00 specialty alignment guides in scope of the non-conformance were returned to stryker and were never brought into the operating room.Because the discrepancy devices were never exposed to the patient or user (i.E.Surgeon) in an operating room environment, nor can they be exposed in the future (as the devices were returned to stryker), they do not represent a hazard.Conclusion: based on the assessment, there are no hazards or associated harms associated with this discrepancy.
Event or Problem Description
After receiving two custom made instruments, we removed them from the packaging and reviewed the instrument before showing the physician.When putting the guide on the inserter we noticed something did not seem correct.I had contacted the rep from the customs instruments decision and sent pictures to see if something was done incorrectly.After sending pictures and the product number stephen noticed that the pin on the modular sleeve is protruding out the wrong side rotating everything 180 degrees in the wrong direction.

• Brand Name: SPECIALTY TRIDENT TRITANIUM ALIGNMENT GUIDE
• 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: 8803337
• Report Number: 0002249697-2019-02598
• Device Sequence Number: 320257
• Product Code: LPH
• UDI-Device Identifier: 07613327347524
• UDI-Public: 07613327347524
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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 Catalogue Number: I-H2022AG00
• Device Lot Number: AL13V16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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