MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH HANSSON PIN TI 90MM; PIN, FIXATION, SMOOTH

Catalog Number 694090S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2013, the patient underwent surgery with the hansson pin system.At the three month check up patient was fine.Six months after, the surgeon found that the femoral head is collapsing because the hook was cut out from the femoral head.The surgeon is planning to remove the device on 7(b)(6) 2014.

Manufacturer Narrative

Device remains implanted.Additional information was requested and if received will be provided on a supplemental report.Device remains implanted.

Manufacturer Narrative

The reported incident could not be confirmed, since no further information is available and the device is not returned for evaluation.Due to lack of details in the information provided it is difficult to make any conclusions on what has caused the cut out of the hansson pin.The use of the implant is very well documented in scientific articles and has shown very good results in its intended use.Cut out is likely to be clinical or patient related rather than implant correlated.In the instructions for use, v15014 rev b non active implant elos medical ifu is stated following: ¿implant selection and sizing: the correct selection of the fracture fixation appliance is extremely important.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.In many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: delayed union or non-union of the fracture site.Conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ avascular necrosis.¿ indications for any material, manufacturing or design related problems were not determined in the investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device and x-rays 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

On (b)(6) 2013, the patient underwent surgery with the hansson pin system.At the three month check up patient was fine.Six months after, the surgeon found that the femoral head is collapsing because the hook was cut out from the femoral head.The surgeon is planning to remove the device on (b)(6) 2014.

• Brand Name: HANSSON PIN TI 90MM
• 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: 4019664
• MDR Text Key: 4843443
• Report Number: 0008031020-2014-00394
• 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: 07/28/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 694090S
• Device Lot Number: T139291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 08/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2013
• 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: 72 YR