MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X420 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18461142S
Health Effect - Clinical Codes	Death (1802); Bone Fracture(s) (1870)
Date of Event	11/19/2014
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.Device disposition is unknown.
Event or Problem Description
The manufacturer became aware of adverse events from the (b)(4) hip fracture register.The title of this report is ¿t2 recon in the (b)(4) hip fracture register¿ which is associated with the t2 recon nailing system, within that report, post-operative complications/ adverse events were reported, which occurred between 2009 and 2017.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 13 events were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision surgery due to sequel after proximal fracture.It was also indicated that patient passed away within 60 days since the revision surgery however the cause and the date of the death will not be disclosed.

• Brand Name: RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X420 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: 7741090
• Report Number: 0009610622-2018-00439
• Device Sequence Number: 1588174
• Product Code: HSB
• UDI-Device Identifier: 07613153316701
• UDI-Public: 07613153316701
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K032898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: literature,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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 Catalogue Number: 18461142S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/01/2018
• 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