MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31301180S
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Product will not be return.
Event or Problem Description
It was reported that there is no broken nail as per attached x-rays, but osteosynthesis itself failed, so revision surgery is required.The surgeon stated that "our opinion why implant failed is inappropriate reposition, we did not restore adams arch.There is visible medial movement of all implant due to laxity in diafysal bole.Dynamic fixation was used.If only stem of the nail was bigger - e.G.13mm or of there is a stop on the end of hip screw - it would prevent medial dislocation of nail.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 5475945
• Report Number: 0009610622-2016-00085
• Device Sequence Number: 401562
• Product Code: HSB
• UDI-Device Identifier: 04546540375124
• UDI-Public: 0104546540375124111511181720103110K043569
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 31301180S
• Device Lot Number: K043569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2016
• Initial Report FDA Received Date: 03/03/2016
• 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: Required Intervention