MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31201180S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

Pseudarthrosis of the pertrochanteric fracture, revision surgery (implantation of total hip prosthesis after removal of the implant.

Manufacturer Narrative

Referring to the product inquiry the trochanteric nail kit, ti gamma3® is the only reported device and thus considered the primary product.Failures in material or manufacturing were not found.Review of the dhr for the reported nail revealed no discrepancies; the device was documented faultless prior to distribution.The nail reported was not returned to stryker (b)(4) due to ¿clinical investigation¿ according to information received.However, no product malfunction was reported.The issue is about a revision to a thp due to pseudarthrosis of the per-trochanteric fracture in a (b)(6) patient after 10 months.The event was reported in the course of the ¿(b)(6)¿ / delayed union.Based on the above observations the root cause of the reported event is not linked to a deficiency of the device but is rather related to the patient¿s condition.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.

Event Description

Pseudarthrosis of the pertrochanteric fracture, revision surgery (implantation of total hip prosthesis after removal of the implant.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6119495
• MDR Text Key: 60622245
• Report Number: 0009610622-2016-00514
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 31201180S
• Device Lot Number: K078772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 56