MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 34251400S

Device Problem Collapse (1099)

Patient Problem Fall (1848)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "the patient had a long gamma implanted approx.8 years ago at (b)(6).The patient fell last week and the femoral head collapsed.The surgeon decided to remove the gamma nail and do a primary tha using accolade ii size 5 and a trident ha hemi cup 52mm.Routine procedure with no complications".

Event Description

As reported: "the patient had a long gamma implanted approx.8 years ago at (b)(6).The patient fell last week and the femoral head collapsed.The surgeon decided to remove the gamma nail and do a primary tha using accolade ii size 5 and a trident ha hemi cup 52mm.Routine procedure with no complications".

Manufacturer Narrative

The reported event that long nail kit r1.5, ti, right gamma3® ø11x400mm x 125° was alleged of 'implant revision / removal without implant breakage' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The event details did not report an implant failure.The root cause of the event is patient related since the collapse of the femoral head was due to the reported fall.The decision to remove the implant was taken by the surgeon, according to his medical expertise about the case.The implant did not break, and has been functional for the past 8 years.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X400MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7655716
• MDR Text Key: 112928934
• Report Number: 0009610622-2018-00254
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613252273851
• UDI-Public: 07613252273851
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 34251400S
• Device Lot Number: K0A26CE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention