MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG K-WIRE, SMOOTH, 1.4MMX100MM; PLATE, FIXATION, BONE

Catalog Number 45-80200S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During variax fibula surgery, an assistant nurse has injured there hand with k-wire.They did not notice that the k-wire is sharp at both ends.The same event is occurred twice.The injury is not serious.The inures' assistant did not require the medical intervention to care for her injury.The injury was quite slight.

• Brand Name: K-WIRE, SMOOTH, 1.4MMX100MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5173985
• MDR Text Key: 29826383
• Report Number: 0008010177-2015-00263
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K063875
• 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: 10/02/2015

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 Catalogue Number: 45-80200S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 10/24/2015
• 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): Other