MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31250170S
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation revealed the trochanteric nail to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The implant was documented as faultless prior to distribution.An inspection was not possible because neither the implant nor x-rays were available.General aspects: one requirement for successful nail treatment is a timely bone healing in order to relive the nail over the progressing time of implantation.In this case the patient had been revised due to non-union of a neck fracture.The location of the neck fracture (medial or lateral) was not specified ¿ thus, it could not be determined if the used nail was suitable for this indication.As no medical records were presented the course of bone healing could not be verified in this case.Non-unions can have several reasons, i.E.Poor fracture reduction, boor bone quality, poor blood supply, bone diseases.Non-unions are listed as adverse effects in the ifu.Based on the given information the case is attributed to patient¿s condition; a relationship to the implant can be excluded because no product deficiency was reported.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.With given information a deficiency of the device was not verified.Device disposition is unknown.
Event or Problem Description
It was reported that during unknown date, an unknown gamma3 short nail was implanted for multiple injury of fracture of a clavicle and the femoral neck fracture.On (b)(6) 2016, surgical treatment again patient was revised to gamma3 long due to nonunion of the femoral neck fracture.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM 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: 6404870
• Report Number: 0009610622-2017-00079
• Device Sequence Number: 13594675
• Product Code: HSB
• UDI-Device Identifier: 04546540375063
• UDI-Public: (01)04546540375063(11)151027(17)200930(10)K0D7631
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2017

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 31250170S
• Device Lot Number: K0D7631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2017
• Initial Report FDA Received Date: 03/14/2017
• 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