MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X42,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965042S
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/15/2018
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
For 1 week without recurrent trauma, increased pain on the hip, left side, after, on (b)(6) 2018 with gamma nail osteosynthesis treated, pertrochanteric femur fracture, left side, with uncomplicated postoperative course and radiologically controlled, proper implant position.
Additional Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
For 1 week without recurrent trauma, increased pain on the hip, left side, after, on (b)(6) 2018 with gamma nail osteosynthesis treated, pertrochanteric femur fracture, left side, with uncomplicated postoperative course and radiologically controlled, proper implant position.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X42,5 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: 7982160
• Report Number: 0009610622-2018-01353
• Device Sequence Number: 11150964
• Product Code: HSB
• UDI-Device Identifier: 04546540382344
• UDI-Public: 04546540382344
• Combination Product (Y/N): N
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 18965042S
• Device Lot Number: K05C3EC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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