MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X260MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-0280S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The patient underwent gamma3 surgery on (b)(6) 2017.When the patient visited a hospital with another disease, shortening of right leg was pointed out, and then transferred to the hospital that the initial surgery was performed.X-ray showed a femoral head perforation but the patient did not feel any pain due to schizophrenia, this was one of the reason why the perforation was advanced in the surgeon's opinion.Revision surgery was performed on (b)(6) 2018, the lag screw which reached intestinal tract was removed with laparoscopic surgery, and the gamma3 nail was removed subsequently.There were no damages noted to the lag screw by a set screw.In the surgeon's opinion, the main reason of the perforation was the set screw was not reached to the lag screw.Femoral head perforation, revision.
Additional Manufacturer Narrative
Correction to catalog number.Referring to the product inquiry the long nail kit r1.5, ti, right gamma3® ø10x260mm x125° and the lag screw, ti gamma3® ø10.5x100mm are subject products.No further associated products were reported.Failures in material or manufacturing were not found.Review of the device history records for the reported devices revealed no discrepancies; the devices were documented faultless prior to distribution.The received long nail, set screw (part of the nail kit) and lag screw show intense traces of use.There are friction marks all over the returned lag screw ¿ under stereo-microscope identified as material abrasion respectively significant bearing points during the period of implantation.The formation of these marks indicates rotation of the lag screw.Nevertheless, no mark or imprint is visible at the ground of one of the four grooves.If the set screw would have been inserted as intended, a small imprint would be visible at the ground of one of the grooves (the superior one).At the returned set screw the thread tips as well as the white ¿nylstop¿ in the middle of the thread of the set screw are worn, but there is neither any mark nor imprint at the tip of the set screw indicating any contact with the lag screw as intended.This clearly indicates that the set screw had not been placed properly as intended in order to avoid rotating movement of the lag screw.During functional testing the set screw was screwed into the returned nail, and it was proved that the set screw could be screwed in as deep as intended.Based on the above the reported event is not linked to a deficiency of the device, but is rather considered user related (deviation from surgical technique).Review of complaint history, capa databases, risk analysis and labelling did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product / product family.No non-conformity was identified.
Event or Problem Description
The patient underwent gamma3 surgery on (b)(6) 2017.When the patient visited a hospital with another disease, shortening of right leg was pointed out, and then transferred to the hospital that the initial surgery was performed.X-ray showed a femoral head perforation but the patient did not feel any pain due to schizophrenia, this was one of the reason why the perforation was advanced in the surgeon's opinion.Revision surgery was performed on (b)(6) 2018, the lag screw which reached intestinal tract was removed with laparoscopic surgery, and the gamma3 nail was removed subsequently.There were no damages noted to the lag screw by a set screw.In the surgeon's opinion, the main reason of the perforation was the set screw was not reached to the lag screw.Femoral head perforation, revision.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X260MM 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
• MDR Report Key: 7383206
• Report Number: 0009610622-2018-00086
• Device Sequence Number: 11081008
• Product Code: HSB
• UDI-Device Identifier: 04546540375315
• UDI-Public: (01)04546540375315
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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: 06/30/2021
• Device Model Number: 3425-0280S
• Device Catalogue Number: 34250260S
• Device Lot Number: K091FAF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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
• Patient Age: 82 YR