MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R, R1500 T2 FEMUR Ø9X280 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18280928S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that femoral nail, a/r, r1500 t2 femur ø9x280 mm was alleged of 'implant breakage - nail' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.As no further information was available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
T2 femoral nail was retrograde inserted into the case with tumor.On (b)(6) 2018, the nail broke in the proximal part.On (b)(6) 2018, the broken part was remained in the patient, the nail was removed and fixed with a plate by revision surgery.

• Brand Name: FEMORAL NAIL, A/R, R1500 T2 FEMUR Ø9X280 MM
• 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: 7870740
• Report Number: 0009610622-2018-01044
• Device Sequence Number: 13949666
• Product Code: HSB
• UDI-Device Identifier: 04546540200259
• UDI-Public: 04546540200259
• Combination Product (Y/N): N
• PMA/510(K) Number: K081152
• 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
• Report Date (Section B): 09/12/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: 18280928S
• Device Lot Number: K09F3A9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/12/2018
• 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