MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-0260S
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
Event or Problem Description
As reported: "the implanting procedure was [performed] for the left femur, but the right implant was implanted.Sr noticed miss implanting the right nail for left femur after procedure.".
Additional Manufacturer Narrative
Correction: device identification (lot #).The reported event could be confirmed, as per reported event the long nail right, engraved as intended, was implanted on left side and no discrepancies with the engraving/marking was reported.As per reported event ¿the surgeon knew that the device was for right side but implanted it with his judgement¿.It lies in the responsibility of the treating surgeon.The ifu clearly points out that an inspection is recommended prior to surgery and an implant utilization that would interfere with anatomical structures or physiological performance is contraindicated.For full instruction please refer to corresponding ifu.A device history review revealed that the originally reported lot code corresponds to a different type of device and not to the reported long nail kit r1.5, ti, right gamma3® ø10x260mm x 125°.The correct lot code could not be obtained.Based on investigation, the root cause was attributed to a user related issue.The failure was likely caused by user-customer-abnormal use.
Event or Problem Description
As reported: "the implanting procedure was [performed] for the left femur, but the right implant was implanted.Sr noticed miss implanting the right nail for left femur after procedure.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 125
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9924838
• Report Number: 0009610622-2020-00139
• Device Sequence Number: 16961869
• Product Code: HSB
• UDI-Device Identifier: 04546540375308
• UDI-Public: 04546540375308
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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 Model Number: 3425-0260S
• Device Catalogue Number: 34250260S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1