MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH HANSSON PIN TI 85MM; PIN, FIXATION, SMOOTH

Catalog Number 694085S

Device Problem Insufficient Information (3190)

Patient Problem Necrosis (1971)

Event Date 05/25/2012

Event Type  Injury  

Event Description

After g3 surgery, the patient developed femoral head necrosis and was revised to a uha.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the reported incident could not be confirmed, since the device was not returned for evaluation.This event was reported during a national surgery meeting and no further information was available.Reviewing the literature and the indication of the hansson pins (reduce the risk of avascular necrosis), it's unlikely that the pins caused this adverse consequence.This can happen under certain conditions like poor fixation.Based on the literature review, this event cannot be attributed to the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Indications for any material, manufacturing or design related problems were not determined in the investigation.Please note that 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.If any further information is provided, the investigation report will be updated.

Event Description

After g3 surgery, the patient developed femoral head necrosis and was revised to a uha.

• Brand Name: HANSSON PIN TI 85MM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 3576560
• MDR Text Key: 21969297
• Report Number: 0008031020-2014-00018
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033968
• 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: 12/18/2013

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: 694085S
• Device Lot Number: T116751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 01/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2011
• 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: 77 YR
• Patient Weight: 45