MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35250360S
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient's left femur was revised due to femoral periprosthetic fracture, and breakage of the nail at the fracture site.Patient was revised to competitor devices.
Event or Problem Description
It was reported that the patient's left femur was revised due to femoral perirprosthetic fracture, and breakage of the nail at the fracture site.Patient was revised to competitor devices.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation.More detailed information about the complaint event as well as the affected device and x-rays must be available in order to determine the root cause of the complaint event.However, based on risk analysis file, some of the possible root causes could be: inadequate handling devices by hcp- e.G.Heavy use of power tool or considering patients stature insufficient, inappropriate use of reamer, inappropriate size of reamer used, excessive forces applied during reaming and nail insertion, wrong selection of the nail (the curvature, length and diameter of selected nail fit the patient's anatomy).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The ifu states: "post-operative ¿ post-operative patient activity: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.¿ the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular post-operative examinations (e.G.X-ray checks) are advisable.¿ the risk of post-operative complication (e.G.Failure of an implant) is higher if patients are obese and/or cannot follow the recommendations of the physician because of any mental or neuromuscular disorder.For this reason, those patients must have additional post-operative follow-up." if device is returned or any further information is provided, the investigation report will be reassessed.Device disposition unknown.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X360MM 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: 8784562
• Report Number: 0009610622-2019-00535
• Device Sequence Number: 2044031
• Product Code: HSB
• UDI-Device Identifier: 04546540375742
• UDI-Public: 04546540375742
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 35250360S
• Device Lot Number: K0E53B9
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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: Required Intervention
• Patient Age: 77 YR