MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE 10 DEG INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	2041C-3254
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There has been one other events for the lot referenced.Not returned.
Event or Problem Description
It was reported that, during a revision tha, when a nurse open the package, our sales staff noticed no locking wire on the insert.A spare was used instead.
Additional Manufacturer Narrative
An event regarding a missing locking wire of a osteonics omnifit series ii crossfire insert was reported.The event was confirmed based on evaluation of returned device.Method & results: -device evaluation and results: the crossfire 10 deg insert catalog #2041c-3254 lot 53778501 was returned for evaluation.Based on visual inspection, it is confirmed that there is no locking wire present on the device.The device was otherwise visually unremarkable with no damage visible on any surface.-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 crossfire 10 deg insert catalog #2041c-3254 lot 53778501 was returned for evaluation.Based on visual inspection, it is confirmed that there is no locking wire present on the device.The device was otherwise visually unremarkable with no damage visible on any surface.The event and returned device was evaluated by the manufacturing cell who initiated an nc as a result of their review.All further investigation into this event will be managed through said nc.
Event or Problem Description
It was reported that, during a revision tha, when a nurse open the package, our sales staff noticed no locking wire on the insert.A spare was used instead.

• Brand Name: CROSSFIRE 10 DEG INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8817357
• Report Number: 0002249697-2019-02635
• Device Sequence Number: 321010
• Product Code: JDI
• UDI-Device Identifier: 04546540035806
• UDI-Public: 04546540035806
• Combination Product (Y/N): N
• PMA/510(K) Number: K974685
• 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): 08/22/2019

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: 11/30/2020
• Device Catalogue Number: 2041C-3254
• Device Lot Number: 53778501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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