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

Catalog Number 694085S

Device Problems Break (1069); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2015

Event Type  malfunction  

Event Description

During hansson pin surgery, the hook of hansson pin did not protrude from the pin completely.It seemed that the thread of introducer handle or inner introducer is damaged.The hansson pin has been inserted as it is and the surgery was finished.

Manufacturer Narrative

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

Manufacturer Narrative

Once the investigation has been completed, the results will be sent in a supplemental report.

Event Description

During hansson pin surgery, the hook of hansson pin did not protrude from the pin completely.It seemed that the thread of introducer handle or inner introducer is damaged.The hansson pin has been inserted as it is and the surgery was finished.

• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4669281
• MDR Text Key: 5687846
• Report Number: 0008031020-2015-00136
• 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: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 694085S
• Device Lot Number: T139272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 04/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other