MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø13X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34253320S
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
In the femoral trochanter fracture, a 13 mm gamma long was prepared.Reaming started from 11 mm, reaming to 14 mm and inserting a gamma long but it stacked.It was further reamed to 15.5 mm and inserted the gamma by hitting with a hammer.After proximal fixation and distal fixation, femoral condylar fracture was noted.Completed the procedure and fixed it with gibbs.
Event or Problem Description
In the femoral trochanter fracture, a 13 mm gamma long was prepared.Reaming started from 11 mm, reaming to 14 mm and inserting a gamma long but it stacked.It was further reamed to 15.5 mm and inserted the gamma by hitting with a hammer.After proximal fixation and distal fixation, femoral condylar fracture was noted.Completed the procedure and fixed it with gibbs.
Additional Manufacturer Narrative
Corrections to concomitant medical products/device evaluated by mfr.The reported event that long nail kit r1.5, ti, right gamma3® ø13x320mm x 125° was alleged of issue (adverse impact on patient / patient related / iatrogenic issue) could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.It cannot be ruled out that the patient is having osteoportic bone (reported age of patient is 95).Based on complaint history and risk analysis file, some of the possible root causes of bone fracture but is not limited to: handling failure (medullary canal is not reamed wide enough or entry point is not correct, too much force used).Choosing inadequate nail geometry improper positioning of implant patient related (osteoporotic bone) distal screw insertion- while extending the trocar with the guide sleeves down to bone excessive force used causes fissures in the bone screw is inserted with too much force and cortex gets fissures misdrilling during distal screw insertion- due to improper target arm alignment.The operative technique clearly mentions the above points must be considered in order to perform a proper procedure.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® Ø13X320MM X 125°
• 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: 7712313
• Report Number: 0009610622-2018-00384
• Device Sequence Number: 19099046
• Product Code: HSB
• UDI-Device Identifier: 04546540406644
• UDI-Public: 04546540406644
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 34253320S
• Device Lot Number: K0D5B0C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 12/20/2018
• 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