MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30660095S

Device Problems Migration or Expulsion of Device (1395); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Primary surgery: (b)(6) 2016.Scheduled revision: (b)(6) 2016.The surgeon allowed the patient to apply a full weight bearing 4 weeks after surgery through the stages of non-weight or partial weight bearing.The surgeon found that the u lag screw has migrated to the femoral head.And he found that the back end of the u lag screw was caught in the nail as of (b)(6).

Manufacturer Narrative

According to investigation (b)(4) the u-blade set did not contribute to the event.Thus, concomitant item.

Event Description

Primary surgery: (b)(6) 2016.Scheduled revision: (b)(6) 2016.The surgeon allowed the patient to apply a full weight bearing 4 weeks after surgery through the stages of non-weight or partial weight bearing.The surgeon found that the u lag screw has migrated to the femoral head.And he found that the back end of the u lag screw was caught in the nail as of (b)(6).

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X95MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6015492
• MDR Text Key: 56926797
• Report Number: 0009610622-2016-00469
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K043431
• 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: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 30660095S
• Device Lot Number: K0D653A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 76 YR