MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X360MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-0360S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned as it was still implanted.If the device or additional information becomes available, it will be provided in a supplemental report.Device remained implanted.
Event or Problem Description
As reported: a (b)(6) year old male patient had operation with gamma nail for femoral trochanteric fracture on (b)(6) 2019 and was discharged without postoperative problems.There was no problem with x-ray after 3 months.However, when he revisited the hospital on (b)(6) 2020 and took an x-ray, it was discovered that the nail had broken.It seems that the nail was overloaded due to the false joint.Revision (tha) is scheduled on (b)(6) 2020.
Event or Problem Description
As reported: a 64-year-old male patient had operation with gamma nail for femoral trochanteric fracture on (b)(6) 2019 and was discharged without postoperative problems.There was no problem with x-ray after 3 months.However, when he revisited the hospital on (b)(6) 2020 and took an x-ray, it was discovered that the nail had broken.It seems that the nail was overloaded due to the false joint.Revision (tha) is scheduled on (b)(6) 2020.
Additional Manufacturer Narrative
The reported event could be confirmed with the help of x-rays received and that it also matches the reported failure mode.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.Based on the provided medical records, the medical opinion was sought from an experienced independent medical expert which revealed the following; ¿the initial fracture was a reverse trochanteric fracture.These are very difficult to treat due to the intrinsic instability of the fracture.Since we only see one direction on the provided x-rays, i cannot judge the initial repositioning properly.Trying to get the best possible stability is key, especially if the after care is 100% weight bearing.Looking at the follow-up x-rays, it seems there already is quite a dislocation in march compared to november.This is an indication for instability and continuous movement at the fracture site.This will prevent the bone from healing.Looking further at the description of the event, it seems that the fracture might not have healed at all in the 6 months after surgery.The gamma-nail is not intended to weight bear for such a long time.If the fracture did not heal, the non-union can be cause of the breakage of the nail, since the nail is not intended to bear that weight/ or those forces at that time after surgery anymore.¿ 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 material, manufacturing or design related problems were found during the investigation.The raw material certificate was reviewed.It corresponds to the material defined on the drawing and to the internal material specification.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause of the failure is predominantly patient factor (mechanical overstressing) and is also supported by the medical expert¿s opinion ¿the gamma-nail is not intended to weight bear for such a long time.If the fracture did not heal, the non-union can be cause of the breakage of the nail, since the nail is not intended to bear that weight/ or those forces at that time after surgery anymore.¿ if the product is returned or any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X360MM 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; DE D-24232
• MDR Report Key: 10150807
• Report Number: 0009610622-2020-00291
• Device Sequence Number: 2163724
• Product Code: HSB
• UDI-Device Identifier: 04546540375353
• UDI-Public: 04546540375353
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: 3425-0360S
• Device Catalogue Number: 34250360S
• Device Lot Number: K0E3FCE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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: 64 YR