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

Catalog Number	30660095S
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was discarded.
Event or Problem 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.
Event or Problem 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 120th october replaced 120 ° gamma nail.
Additional Manufacturer Narrative
The reported event that u-blade set, ti gamma3® ø10.5x95mm was alleged of issue (implant migration - lag screw) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the complaint history and the risk management file, some of the possible causes for such failure are, patient's general condition (osteoporosis), primly the respective surgical technique (correct positioning of the lag screw in the center of the femoral head), and unscrewing the set screw for more than ¼ of a turn resulting in exceeded motion of the lag screw.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X95MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8074990
• Report Number: 0009610622-2018-01381
• Device Sequence Number: 13857102
• Product Code: HSB
• UDI-Device Identifier: 04546540595997
• UDI-Public: 04546540595997
• Combination Product (Y/N): N
• PMA/510(K) Number: K043431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 30660095S
• Device Lot Number: K0EB4B4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR