MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø12X300 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1845-1230S
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.It was disposed in the hospital.
Event or Problem Description
It was reported that on (b)(6) 2017: the t2recon nail was implanted for femoral trochanteric fracture.In (b)(6) 2018: the patient had pain (the patient did not fall down) and the nail fracture was observed in hospital.On (b)(6) 2018: fractured t2 nail was removed and the revision surgery was done with non stryker nail.
Additional Manufacturer Narrative
The reported event that reconstruction nail r1.5, ti, right t2 recon ø12x300 mm x 125° was alleged of 'implant breakage - nail' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided, despite multiple attempts.Based on investigation, the root cause was attributed to be patient related.The failure was caused by a possible non union.See implantation date / revision date below.Also see below labelling review for details.On (b)(6) 2017: thet2recon nail was implanted for femoral trochanteric fracture.On (b)(6) 2018: the patient had pain (the patient did not fall down) and the nail fracture was observed in hospital.On (b)(6) 2018: fractured t2 nail was removed and the revision surgery was done with non stryker nail.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that on (b)(6) 2017: the t2recon nail was implanted for femoral trochanteric fracture.On (b)(6) 2018: the patient had pain (the patient did not fall down) and the nail fracture was observed in hospital.On (b)(6) 2018: fractured t2 nail was removed and the revision surgery was done with non stryker nail.

• Brand Name: RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø12X300 MM 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: 7531485
• Report Number: 0009610622-2018-00210
• Device Sequence Number: 13866047
• Product Code: HSB
• UDI-Device Identifier: 04546540412775
• UDI-Public: (01)04546540412775
• Combination Product (Y/N): N
• PMA/510(K) Number: K102992
• 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): 06/20/2018

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: 01/08/2019
• Device Model Number: 1845-1230S
• Device Catalogue Number: 18451230S
• Device Lot Number: K0EA460
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/20/2018
• 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: 88 YR