MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT; IMPLANT

Catalog Number UNK_TNE

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 06/28/2014

Event Type  Injury  

Event Description

After variax elbow surgery, patient fell down and re-fracture has occurred.Revision surgery was performed.

Manufacturer Narrative

The root cause of the reported event could not be determined as the reported device was not returned for evaluation.If any further information is provided, the investigation report will be 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.Based on the event description, most likely the reported problem is related to an excessive mechanical overload on the implant side applied due to the reported impact.Stryker elbow plate configurations are designed in order to provide sufficient mechanical stability to allow early postoperative rehabilitation with a reduced loading protocol.Furthermore, specific post- operative precautions should be taken by the patient.The device cannot and does not replicate a normal healthy bone, and it can break or become damaged as a result of strenuous activity, mal-union, non-union or trauma, as the one reported (as per ifus).The following statements are addressing the reported event: ifus for non-active implant, v15013/j xx/11 review.Variax elbow plating system operative technique: 982335 rev.2.A review of the device history record was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Device was not returned.

• Brand Name: UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4204079
• MDR Text Key: 17572829
• Report Number: 0008031020-2014-00514
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2014

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_TNE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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