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

Catalog Number 30660095S

Device Problem Migration (4003)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Cut out of u lag screw occurs. Patient felt pain on his hip for several weeks and difficult to walk. Then, when falling on 18th, visited in the hospital and an x - ray film was taken, it turned out that the lag screw had cut out and reached the acetabular. There is no dislocation of the pieces of the bony skull, and only the lag screw has cut out. As a measure after occurrence, on 12th october replaced 120 ° gamma nail.

• 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: 8074990
• MDR Text Key: 127341368
• Report Number: 0009610622-2018-01381
• 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

• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 30660095S
• Device Lot Number: K0EB4B4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/15/2018 Patient Sequence Number: 1